parallel randomized trial
AMPLITUDE-O
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Efpeglenatide on Cardiovascular Outcomes in Type 2 Diabetes Patients at High Cardiovascular Risk
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Placebo Placebo | standard of care; lifestyle: not reported | 1,359 | 1,359 | |
| A2 | Efpeglenatide 4 mg subcutaneous once weekly Efpeglenatide 4 mg | standard of care; lifestyle: not reported | 1,359 | ||
| A3 | Efpeglenatide 6 mg subcutaneous once weekly Efpeglenatide 6 mg | standard of care; lifestyle: not reported | 1,358 | ||
| A4 | Pooled Efpeglenatide 4 mg and 6 mg pooled | standard of care; lifestyle: not reported | 2,717 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Placebo A1 | Efpeglenatide 4 mg subcutaneous once weekly A2 | Efpeglenatide 6 mg subcutaneous once weekly A3 | Pooled A4 | Whole trial ALL |
|---|---|---|---|---|---|---|
| age | mean (years) | 64.4 | 64.6 | 64.7 | ||
| age | sd (years) | 8.3 | 8.2 | 8.2 | ||
| asian | n | 98 | 87 | 82 | ||
| black | n | 50 | 38 | 55 | ||
| bmi | mean (kg/m2) | 32.40 | 32.81 | 32.90 | ||
| bmi | sd (kg/m2) | 6.01 | 6.22 | 6.21 | ||
| diabetes duration | mean (years) | 15.4 | ||||
| established cvd | percent | 89.6 | ||||
| female | n | 419 | 442 | 483 | ||
| hba1c | mean (percent) | 8.9 | ||||
| other race american indian alaska native | n | 11 | 8 | 8 | ||
| other race multiple | n | 4 | 9 | 5 | ||
| other race native hawaiian pacific islander | n | 0 | 1 | 2 | ||
| sglt2i use | n | 618 | ||||
| sglt2i use | percent | 15.2 | ||||
| white | n | 1162 | 1192 | 1180 |
Results
168 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (9 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 94.45 | A1 | change | -0.16 percent | 0.07 | not stated; other; background:no_sglt2i; R0004602:Table 2 | ||
| 94.45 | A1 | change | -0.23 percent | 0.09 | not stated; other; background:sglt2i; R0004602:Table 2 | ||
| 94.45 | A2 vs A1 | md | -1.2 percent | -1.3 to -1.1 | not stated; other; R0011485:Supplement Table S1 | ||
| 94.45 | A3 vs A1 | md | -1.3 percent | -1.4 to -1.24 | not stated; other; R0011485:Supplement Table S2 | ||
| 94.45 | A4 vs A1 | md | -1.25 percent | -1.3 to -1.2 | not stated; other; R0011485:Table 2 | ||
| 94.45 | A4 vs A1 | md | -1.06 percent | -1.21 to -0.91 | not stated; other; background:sglt2i; R0004602:Table 2 | ||
| 94.45 | A4 | change | -1.43 percent | 0.07 | not stated; other; background:no_sglt2i; R0004602:Table 2 | ||
| 94.45 | A4 vs A1 | md | -1.27 percent | -1.36 to -1.19 | not stated; other; background:no_sglt2i; R0004602:Table 2 | ||
| 94.45 | A4 | change | -1.29 percent | 0.07 | not stated; other; background:sglt2i; R0004602:Table 2 |
Body weight change in kilograms (diabetes) (9 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 94.45 | A1 | change | -0.42 kg | 0.36 | not stated; other; background:sglt2i; R0004602:Table 2 | ||
| 94.45 | A1 | change | -0.86 kg | 0.29 | not stated; other; background:no_sglt2i; R0004602:Table 2 | ||
| 94.45 | A2 vs A1 | md | -2.5 kg | -2.8 to -2.1 | not stated; other; R0011485:Supplement Table S1 | ||
| 94.45 | A3 vs A1 | md | -2.7 kg | -3.1 to -2.4 | not stated; other; R0011485:Supplement Table S2 | ||
| 94.45 | A4 vs A1 | md | -2.6 kg | -2.9 to -2.3 | not stated; other; R0011485:Table 2 | ||
| 94.45 | A4 | change | -3.45 kg | 0.27 | not stated; other; background:no_sglt2i; R0004602:Table 2 | ||
| 94.45 | A4 vs A1 | md | -2.59 kg | -2.93 to -2.25 | not stated; other; background:no_sglt2i; R0004602:Table 2 | ||
| 94.45 | A4 | change | -3.06 kg | 0.28 | not stated; other; background:sglt2i; R0004602:Table 2 | ||
| 94.45 | A4 vs A1 | md | -2.64 kg | -3.32 to -1.97 | not stated; other; background:sglt2i; R0004602:Table 2 |
Level 2 or 3 hypoglycemia (participants) (15 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 1355 | while on treatment; safety; registry:adverse_events | ||||
| A1 | events | 37 / 1355 | while on treatment; safety; registry:adverse_events | ||||
| A1 | events | 0 / 1355 | while on treatment; safety; registry:adverse_events | ||||
| A1 | events | 0 / 1355 | while on treatment; safety; registry:adverse_events | ||||
| A1 | events | 4 / 1355 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 73 / 1360 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 8 / 1360 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 1 / 1360 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 0 / 1360 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 2 / 1360 | while on treatment; safety; registry:adverse_events | ||||
| A3 | events | 53 / 1358 | while on treatment; safety; registry:adverse_events | ||||
| A3 | events | 4 / 1358 | while on treatment; safety; registry:adverse_events | ||||
| A3 | events | 0 / 1358 | while on treatment; safety; registry:adverse_events | ||||
| A3 | events | 2 / 1358 | while on treatment; safety; registry:adverse_events | ||||
| A3 | events | 2 / 1358 | while on treatment; safety; registry:adverse_events |
Level 2 or 3 hypoglycemia (episode rate) (15 lines; O04B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | rate | 1355 | while on treatment; safety; registry:adverse_events | ||||
| A1 | rate | 1355 | while on treatment; safety; registry:adverse_events | ||||
| A1 | rate | 1355 | while on treatment; safety; registry:adverse_events | ||||
| A1 | rate | 1355 | while on treatment; safety; registry:adverse_events | ||||
| A1 | rate | 1355 | while on treatment; safety; registry:adverse_events | ||||
| A2 | rate | 1360 | while on treatment; safety; registry:adverse_events | ||||
| A2 | rate | 1360 | while on treatment; safety; registry:adverse_events | ||||
| A2 | rate | 1360 | while on treatment; safety; registry:adverse_events | ||||
| A2 | rate | 1360 | while on treatment; safety; registry:adverse_events | ||||
| A2 | rate | 1360 | while on treatment; safety; registry:adverse_events | ||||
| A3 | rate | 1358 | while on treatment; safety; registry:adverse_events | ||||
| A3 | rate | 1358 | while on treatment; safety; registry:adverse_events | ||||
| A3 | rate | 1358 | while on treatment; safety; registry:adverse_events | ||||
| A3 | rate | 1358 | while on treatment; safety; registry:adverse_events | ||||
| A3 | rate | 1358 | while on treatment; safety; registry:adverse_events |
Acute kidney injury (3 lines; O121)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 9 / 1355 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 10 / 1360 | while on treatment; safety; registry:adverse_events | ||||
| A3 | events | 10 / 1358 | while on treatment; safety; registry:adverse_events |
All cause mortality (3 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 49 / 1355 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 40 / 1360 | while on treatment; safety; registry:adverse_events | ||||
| A3 | events | 25 / 1358 | while on treatment; safety; registry:adverse_events |
Three point MACE (7 lines; O21)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 125 / 1359 | not stated; randomized; R0011485:Results | ||||
| A4 | events | 189 / 2717 | not stated; randomized; R0011485:Results | ||||
| A4 vs A1 | hr | 0.73 | 0.58 to 0.92 | not stated; randomized; R0004602:Results | |||
| A4 vs A1 | hr | 0.70 | 0.53 to 0.92 | not stated; other; background:metformin; R0007143:Figure 4 | |||
| A4 vs A1 | hr | 0.80 | 0.54 to 1.20 | not stated; other; background:no_metformin; R0007143:Figure 4 | |||
| A4 vs A1 | hr | 0.74 | 0.58 to 0.94 | not stated; other; background:no_sglt2i; R0004602:Figure 1 | |||
| A4 vs A1 | hr | 0.70 | 0.37 to 1.30 | not stated; other; background:sglt2i; R0004602:Figure 1 |
Four point MACE including unstable angina (3 lines; O21B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 158 / 1359 | not stated; randomized; R0016950:Figure 1 | ||||
| A4 vs A1 | hr | 0.79 | 0.65 to 0.96 | not stated; randomized; R0004602:Results | |||
| A4 | events | 257 / 2717 | not stated; randomized; R0016950:Figure 1 |
Kidney composite including albuminuria or smaller eGFR declines (1 lines; O22E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A4 vs A1 | hr | 0.68 | 0.57 to 0.79 | not stated; randomized; R0004602:Results |
Hospitalization for heart failure (13 lines; O23)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 12 / 1355 | while on treatment; safety; cardiac failure; registry:adverse_events | ||||
| A1 | events | 3 / 1355 | while on treatment; safety; cardiac failure acute; registry:adverse_events | ||||
| A1 | events | 2 / 1355 | while on treatment; safety; cardiac failure chronic; registry:adverse_events | ||||
| A1 | events | 3 / 1355 | while on treatment; safety; cardiac failure congestive; registry:adverse_events | ||||
| A2 | events | 2 / 1360 | while on treatment; safety; cardiac failure congestive; registry:adverse_events | ||||
| A2 | events | 1 / 1360 | while on treatment; safety; cardiac failure acute; registry:adverse_events | ||||
| A2 | events | 4 / 1360 | while on treatment; safety; cardiac failure chronic; registry:adverse_events | ||||
| A2 | events | 4 / 1360 | while on treatment; safety; cardiac failure; registry:adverse_events | ||||
| A3 | events | 0 / 1358 | while on treatment; safety; cardiac failure acute; registry:adverse_events | ||||
| A3 | events | 1 / 1358 | while on treatment; safety; cardiac failure chronic; registry:adverse_events | ||||
| A3 | events | 2 / 1358 | while on treatment; safety; cardiac failure congestive; registry:adverse_events | ||||
| A3 | events | 1 / 1358 | while on treatment; safety; cardiac failure; registry:adverse_events | ||||
| A4 vs A1 | hr | 0.61 | 0.38 to 0.98 | not stated; randomized; R0004602:Results |
Serious adverse events (3 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 298 / 1355 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 312 / 1360 | while on treatment; safety; registry:adverse_events | ||||
| A3 | events | 275 / 1358 | while on treatment; safety; registry:adverse_events |
Discontinuation due to adverse events (3 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 49 / 1359 | not stated; randomized; registry:flow | ||||
| A2 | events | 68 / 1359 | not stated; randomized; registry:flow | ||||
| A3 | events | 79 / 1358 | not stated; randomized; registry:flow |
Nausea (6 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 51 / 1355 | while on treatment; safety; registry:adverse_events | ||||
| A1 | events | 0 / 1355 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 1 / 1360 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 196 / 1360 | while on treatment; safety; registry:adverse_events | ||||
| A3 | events | 167 / 1358 | while on treatment; safety; registry:adverse_events | ||||
| A3 | events | 0 / 1358 | while on treatment; safety; registry:adverse_events |
Vomiting (6 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 18 / 1355 | while on treatment; safety; registry:adverse_events | ||||
| A1 | events | 1 / 1355 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 85 / 1360 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 3 / 1360 | while on treatment; safety; registry:adverse_events | ||||
| A3 | events | 75 / 1358 | while on treatment; safety; registry:adverse_events | ||||
| A3 | events | 0 / 1358 | while on treatment; safety; registry:adverse_events |
Diarrhea (6 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 64 / 1355 | while on treatment; safety; registry:adverse_events | ||||
| A1 | events | 3 / 1355 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 116 / 1360 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 2 / 1360 | while on treatment; safety; registry:adverse_events | ||||
| A3 | events | 117 / 1358 | while on treatment; safety; registry:adverse_events | ||||
| A3 | events | 1 / 1358 | while on treatment; safety; registry:adverse_events |
Gallbladder and biliary disease (21 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 1355 | while on treatment; safety; cholecystitis acute; registry:adverse_events | ||||
| A1 | events | 0 / 1355 | while on treatment; safety; bile duct stone; registry:adverse_events | ||||
| A1 | events | 1 / 1355 | while on treatment; safety; cholangitis infective; registry:adverse_events | ||||
| A1 | events | 0 / 1355 | while on treatment; safety; hyperplastic cholecystopathy; registry:adverse_events | ||||
| A1 | events | 0 / 1355 | while on treatment; safety; cholecystitis chronic; registry:adverse_events | ||||
| A1 | events | 1 / 1355 | while on treatment; safety; cholecystitis; registry:adverse_events | ||||
| A1 | events | 2 / 1355 | while on treatment; safety; cholelithiasis; registry:adverse_events | ||||
| A2 | events | 4 / 1360 | while on treatment; safety; cholecystitis; registry:adverse_events | ||||
| A2 | events | 0 / 1360 | while on treatment; safety; bile duct stone; registry:adverse_events | ||||
| A2 | events | 1 / 1360 | while on treatment; safety; hyperplastic cholecystopathy; registry:adverse_events | ||||
| A2 | events | 0 / 1360 | while on treatment; safety; cholangitis infective; registry:adverse_events | ||||
| A2 | events | 1 / 1360 | while on treatment; safety; cholelithiasis; registry:adverse_events | ||||
| A2 | events | 4 / 1360 | while on treatment; safety; cholecystitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 1360 | while on treatment; safety; cholecystitis chronic; registry:adverse_events | ||||
| A3 | events | 2 / 1358 | while on treatment; safety; bile duct stone; registry:adverse_events | ||||
| A3 | events | 0 / 1358 | while on treatment; safety; hyperplastic cholecystopathy; registry:adverse_events | ||||
| A3 | events | 3 / 1358 | while on treatment; safety; cholecystitis acute; registry:adverse_events | ||||
| A3 | events | 2 / 1358 | while on treatment; safety; cholecystitis chronic; registry:adverse_events | ||||
| A3 | events | 3 / 1358 | while on treatment; safety; cholecystitis; registry:adverse_events | ||||
| A3 | events | 1 / 1358 | while on treatment; safety; cholelithiasis; registry:adverse_events | ||||
| A3 | events | 0 / 1358 | while on treatment; safety; cholangitis infective; registry:adverse_events |
Acute pancreatitis (6 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 4 / 1355 | while on treatment; safety; registry:adverse_events | ||||
| A1 | events | 1 / 1355 | while on treatment; safety; obstructive pancreatitis; registry:adverse_events | ||||
| A2 | events | 3 / 1360 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 1 / 1360 | while on treatment; safety; obstructive pancreatitis; registry:adverse_events | ||||
| A3 | events | 2 / 1358 | while on treatment; safety; registry:adverse_events | ||||
| A3 | events | 1 / 1358 | while on treatment; safety; obstructive pancreatitis; registry:adverse_events |
Thyroid cancer (any) (6 lines; O32B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 1355 | while on treatment; safety; registry:adverse_events | ||||
| A1 | events | 0 / 1355 | while on treatment; safety; papillary thyroid cancer; registry:adverse_events | ||||
| A2 | events | 0 / 1360 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 1 / 1360 | while on treatment; safety; papillary thyroid cancer; registry:adverse_events | ||||
| A3 | events | 1 / 1358 | while on treatment; safety; registry:adverse_events | ||||
| A3 | events | 0 / 1358 | while on treatment; safety; papillary thyroid cancer; registry:adverse_events |
Diabetic retinopathy complications (3 lines; O33)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 1355 | while on treatment; safety; vitreous haemorrhage; registry:adverse_events | ||||
| A2 | events | 0 / 1360 | while on treatment; safety; vitreous haemorrhage; registry:adverse_events | ||||
| A3 | events | 1 / 1358 | while on treatment; safety; vitreous haemorrhage; registry:adverse_events |
Suicidal ideation or behavior (3 lines; O35A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 1355 | while on treatment; safety; suicidal ideation; registry:adverse_events | ||||
| A2 | events | 0 / 1360 | while on treatment; safety; suicidal ideation; registry:adverse_events | ||||
| A3 | events | 1 / 1358 | while on treatment; safety; suicidal ideation; registry:adverse_events |
Gastroparesis (3 lines; O37A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 1355 | while on treatment; safety; diabetic gastroparesis; registry:adverse_events | ||||
| A2 | events | 0 / 1360 | while on treatment; safety; diabetic gastroparesis; registry:adverse_events | ||||
| A3 | events | 0 / 1358 | while on treatment; safety; diabetic gastroparesis; registry:adverse_events |
Intestinal obstruction or ileus (15 lines; O37B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 1355 | while on treatment; safety; ileus; registry:adverse_events | ||||
| A1 | events | 1 / 1355 | while on treatment; safety; intestinal obstruction; registry:adverse_events | ||||
| A1 | events | 0 / 1355 | while on treatment; safety; mechanical ileus; registry:adverse_events | ||||
| A1 | events | 0 / 1355 | while on treatment; safety; small intestinal obstruction; registry:adverse_events | ||||
| A1 | events | 0 / 1355 | while on treatment; safety; subileus; registry:adverse_events | ||||
| A2 | events | 1 / 1360 | while on treatment; safety; ileus; registry:adverse_events | ||||
| A2 | events | 0 / 1360 | while on treatment; safety; intestinal obstruction; registry:adverse_events | ||||
| A2 | events | 0 / 1360 | while on treatment; safety; mechanical ileus; registry:adverse_events | ||||
| A2 | events | 1 / 1360 | while on treatment; safety; small intestinal obstruction; registry:adverse_events | ||||
| A2 | events | 0 / 1360 | while on treatment; safety; subileus; registry:adverse_events | ||||
| A3 | events | 0 / 1358 | while on treatment; safety; ileus; registry:adverse_events | ||||
| A3 | events | 2 / 1358 | while on treatment; safety; intestinal obstruction; registry:adverse_events | ||||
| A3 | events | 1 / 1358 | while on treatment; safety; mechanical ileus; registry:adverse_events | ||||
| A3 | events | 1 / 1358 | while on treatment; safety; small intestinal obstruction; registry:adverse_events | ||||
| A3 | events | 1 / 1358 | while on treatment; safety; subileus; registry:adverse_events |
Pancreatic cancer (9 lines; O38)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 1355 | while on treatment; safety; adenocarcinoma pancreas; registry:adverse_events | ||||
| A1 | events | 1 / 1355 | while on treatment; safety; pancreatic carcinoma metastatic; registry:adverse_events | ||||
| A1 | events | 1 / 1355 | while on treatment; safety; pancreatic carcinoma; registry:adverse_events | ||||
| A2 | events | 0 / 1360 | while on treatment; safety; adenocarcinoma pancreas; registry:adverse_events | ||||
| A2 | events | 0 / 1360 | while on treatment; safety; pancreatic carcinoma metastatic; registry:adverse_events | ||||
| A2 | events | 0 / 1360 | while on treatment; safety; pancreatic carcinoma; registry:adverse_events | ||||
| A3 | events | 0 / 1358 | while on treatment; safety; adenocarcinoma pancreas; registry:adverse_events | ||||
| A3 | events | 0 / 1358 | while on treatment; safety; pancreatic carcinoma metastatic; registry:adverse_events | ||||
| A3 | events | 1 / 1358 | while on treatment; safety; pancreatic carcinoma; registry:adverse_events |