Trial Outcomes & Findings for A Study of SHR-1210 in Combination With Apatinib or Chemotherapy in Subjects With Advanced PLC or BTC (NCT NCT03092895)
NCT ID: NCT03092895
Last Updated: 2026-01-29
Results Overview
The incidence of adverse events (AEs) and Serious adverse events (SAEs) assessed by NCI-CTCAE v4.03
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
157 participants
Primary outcome timeframe
Up to approximately 4 years
Results posted on
2026-01-29
Participant Flow
Participant milestones
| Measure |
Arm A：SHR-1210+Apatinib
SHR-1210: 3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days.
Apatinib mesylate: Orally administered, once daily, with four dose groups: 125 mg, 250 mg, 375 mg, and 500 mg, for dose exploration from low dose to high dose.
|
Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)
SHR-1210 + FOLFOX4 Q2W： SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days； FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
|
Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W:D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
Arm B：Others
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W:D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
34
|
92
|
3
|
|
Overall Study
COMPLETED
|
28
|
34
|
92
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm A：SHR-1210+Apatinib
n=28 Participants
SHR-1210: 3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days.
Apatinib mesylate: Orally administered, once daily, with four dose groups: 125 mg, 250 mg, 375 mg, and 500 mg, for dose exploration from low dose to high dose.
|
Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)
n=34 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
|
Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)
n=92 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W：D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
Arm B：Others
n=3 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W： D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50.6 years
STANDARD_DEVIATION 9.77 • n=28 Participants
|
52.2 years
STANDARD_DEVIATION 8.75 • n=34 Participants
|
53.9 years
STANDARD_DEVIATION 9.71 • n=92 Participants
|
53.0 years
STANDARD_DEVIATION 13.00 • n=3 Participants
|
52.9 years
STANDARD_DEVIATION 9.54 • n=157 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=28 Participants
|
3 Participants
n=34 Participants
|
37 Participants
n=92 Participants
|
2 Participants
n=3 Participants
|
49 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=28 Participants
|
31 Participants
n=34 Participants
|
55 Participants
n=92 Participants
|
1 Participants
n=3 Participants
|
108 Participants
n=157 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Up to approximately 4 yearsPopulation: The primary safety endpoint was analyzed in SS. The SS included all participants who were treated .
The incidence of adverse events (AEs) and Serious adverse events (SAEs) assessed by NCI-CTCAE v4.03
Outcome measures
| Measure |
Arm A：SHR-1210+Apatinib
n=28 Participants
SHR-1210: 3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days.
Apatinib mesylate: Orally administered, once daily, with four dose groups: 125 mg, 250 mg, 375 mg, and 500 mg, for dose exploration from low dose to high dose.
|
Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)
n=34 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
|
Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)
n=92 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W:D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
Arm B：Others
n=3 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W:D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
|---|---|---|---|---|
|
The Safety and Tolerability
Number of Subjects with AEs
|
28 participants
|
34 participants
|
92 participants
|
3 participants
|
|
The Safety and Tolerability
Number of Subjects with SAEs
|
14 participants
|
20 participants
|
58 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Up to approximately 4 yearsPopulation: The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were treated.
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) assessed by investigator: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm A：SHR-1210+Apatinib
n=28 Participants
SHR-1210: 3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days.
Apatinib mesylate: Orally administered, once daily, with four dose groups: 125 mg, 250 mg, 375 mg, and 500 mg, for dose exploration from low dose to high dose.
|
Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)
n=34 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
|
Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)
n=92 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W:D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
Arm B：Others
n=3 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W:D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
10.7 percentage of participants
Interval 2.3 to 28.2
|
29.4 percentage of participants
Interval 15.1 to 47.5
|
16.3 percentage of participants
Interval 9.4 to 25.5
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
SECONDARY outcome
Timeframe: Up to approximately 4 yearsPopulation: The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were treated.
The time from the date of the first recorded objective tumor response (assessed as per RECIST V1.1) to the date of the first recorded objective tumor progression (assessed as per RECIST V1.1) or the date of death due to any cause, whichever occurs first, in subjects with a BOR of CR or PR.
Outcome measures
| Measure |
Arm A：SHR-1210+Apatinib
n=28 Participants
SHR-1210: 3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days.
Apatinib mesylate: Orally administered, once daily, with four dose groups: 125 mg, 250 mg, 375 mg, and 500 mg, for dose exploration from low dose to high dose.
|
Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)
n=34 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
|
Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)
n=92 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W:D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
Arm B：Others
n=3 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W:D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
|---|---|---|---|---|
|
Duration of Response (DoR)
|
11.30 months
Interval 11.3 to 11.3
|
7.10 months
Interval 3.3 to 29.7
|
7.10 months
Interval 3.6 to 20.2
|
7.20 months
Interval 7.2 to 7.2
|
SECONDARY outcome
Timeframe: Up to approximately 4 yearsPopulation: The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were treated.
The percentage of subjects with a BOR of CR, PR, and SD as per RECIST V1.1. BOR of CR or PR must be confirmed at least 4 weeks (28 days) after the initial assessment.
Outcome measures
| Measure |
Arm A：SHR-1210+Apatinib
n=28 Participants
SHR-1210: 3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days.
Apatinib mesylate: Orally administered, once daily, with four dose groups: 125 mg, 250 mg, 375 mg, and 500 mg, for dose exploration from low dose to high dose.
|
Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)
n=34 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
|
Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)
n=92 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W:D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
Arm B：Others
n=3 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W:D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
64.3 percentage of participants
Interval 44.1 to 81.4
|
79.4 percentage of participants
Interval 62.1 to 91.3
|
75.0 percentage of participants
Interval 64.9 to 83.4
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
SECONDARY outcome
Timeframe: Up to approximately 4 yearsPopulation: The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were treated.
The time from the date of the first dose to the date of radiographic PD (assessed by the investigator as per RECIST V1.1).PD is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or significant progression of non-target lesions leading to discontinuation of therapy, or the appearance of new lesions.
Outcome measures
| Measure |
Arm A：SHR-1210+Apatinib
n=28 Participants
SHR-1210: 3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days.
Apatinib mesylate: Orally administered, once daily, with four dose groups: 125 mg, 250 mg, 375 mg, and 500 mg, for dose exploration from low dose to high dose.
|
Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)
n=34 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
|
Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)
n=92 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W:D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
Arm B：Others
n=3 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W:D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
|---|---|---|---|---|
|
Time to Progression (TTP)
|
3.7 months
Interval 2.0 to 5.7
|
5.7 months
Interval 3.8 to 9.2
|
5.5 months
Interval 3.7 to 7.3
|
2.0 months
Interval 1.8 to
not reached (due to insufficient number of subjects with events).
|
SECONDARY outcome
Timeframe: Up to approximately 4 yearsPopulation: The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were treated.
The time from the date of the first dose to death due to any cause. Overal Survial will be calculated based on Kaplan-Meier estimates
Outcome measures
| Measure |
Arm A：SHR-1210+Apatinib
n=28 Participants
SHR-1210: 3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days.
Apatinib mesylate: Orally administered, once daily, with four dose groups: 125 mg, 250 mg, 375 mg, and 500 mg, for dose exploration from low dose to high dose.
|
Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)
n=34 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
|
Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)
n=92 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W:D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
Arm B：Others
n=3 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W:D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
|---|---|---|---|---|
|
Overall Survival
|
13.3 months
Interval 8.9 to 18.6
|
11.7 months
Interval 8.2 to 19.0
|
10.7 months
Interval 7.7 to 15.4
|
17.6 months
Interval 4.8 to
not reached (due to insufficient number of subjects with events)
|
SECONDARY outcome
Timeframe: Up to approximately 4 yearsPopulation: The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were treated.
The time from the date of the first dose to the date of the first recorded tumor response (assessed as per RECIST V1.1) in subjects with a BOR of CR or PR.
Outcome measures
| Measure |
Arm A：SHR-1210+Apatinib
n=28 Participants
SHR-1210: 3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days.
Apatinib mesylate: Orally administered, once daily, with four dose groups: 125 mg, 250 mg, 375 mg, and 500 mg, for dose exploration from low dose to high dose.
|
Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)
n=34 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
|
Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)
n=92 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W:D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
Arm B：Others
n=3 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W:D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
|---|---|---|---|---|
|
Time to Response (TTR)
|
3.65 months
Interval 1.8 to 3.7
|
1.99 months
Interval 1.5 to 5.6
|
1.84 months
Interval 1.7 to 5.7
|
1.87 months
Interval 1.87 to 1.87
|
SECONDARY outcome
Timeframe: Up to approximately 4 yearsPopulation: The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were treated.
The time from the date of the first dose to the date of the first recorded tumor progression (assessed as per RECIST V1.1) or the date of death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Arm A：SHR-1210+Apatinib
n=28 Participants
SHR-1210: 3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days.
Apatinib mesylate: Orally administered, once daily, with four dose groups: 125 mg, 250 mg, 375 mg, and 500 mg, for dose exploration from low dose to high dose.
|
Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)
n=34 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
|
Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)
n=92 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W:D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
Arm B：Others
n=3 Participants
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W:D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
3.7 months
Interval 2.0 to 5.7
|
5.7 months
Interval 3.8 to 9.2
|
5.3 months
Interval 3.7 to 5.7
|
2.0 months
Interval 1.8 to
not reached (due to insufficient number of subjects with events).
|
Adverse Events
Arm A：SHR-1210+Apatinib
Serious events: 14 serious events
Other events: 28 other events
Deaths: 11 deaths
Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)
Serious events: 20 serious events
Other events: 34 other events
Deaths: 11 deaths
Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)
Serious events: 58 serious events
Other events: 92 other events
Deaths: 35 deaths
Arm B：Others
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A：SHR-1210+Apatinib
n=28 participants at risk
SHR-1210: 3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days.
Apatinib mesylate: Orally administered, once daily, with four dose groups: 125 mg, 250 mg, 375 mg, and 500 mg, for dose exploration from low dose to high dose.
|
Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)
n=34 participants at risk
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days； FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
|
Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)
n=92 participants at risk
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days； FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W： D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
Arm B：Others
n=3 participants at risk
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W：D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Hepatic failure
|
14.3%
4/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.8%
3/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.6%
7/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Hepatorenal failure
|
3.6%
1/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.3%
3/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.3%
3/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.3%
3/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
10.7%
3/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.3%
3/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
3.6%
1/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.4%
5/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.1%
2/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.6%
1/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
2/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Multiple organ dysfunction syndrome
|
10.7%
3/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
11.8%
4/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.6%
7/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Disease progression
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
2/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.9%
10/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pyrexia
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.6%
7/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Asthenia
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Fatigue
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Death
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
4/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Herpes zoster
|
3.6%
1/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pneumonia
|
3.6%
1/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.6%
7/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
2/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Platelet count decreased
|
3.6%
1/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
2/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Hepatic enzyme abnormal
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
2/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
2/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
2/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Renal failure
|
3.6%
1/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
2/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
3.6%
1/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
11.8%
4/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
2/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
2/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.3%
3/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.3%
3/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
2/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Circulatory collapse
|
3.6%
1/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.6%
1/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
2/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Reactive capillary endothelial proliferation
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
2/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
2/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Eating disorder
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Other adverse events
| Measure |
Arm A：SHR-1210+Apatinib
n=28 participants at risk
SHR-1210: 3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days.
Apatinib mesylate: Orally administered, once daily, with four dose groups: 125 mg, 250 mg, 375 mg, and 500 mg, for dose exploration from low dose to high dose.
|
Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)
n=34 participants at risk
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days； FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
|
Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)
n=92 participants at risk
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days； FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W： D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
Arm B：Others
n=3 participants at risk
SHR-1210：3 mg/kg, intravenously infused within 30 min, not less than 20 min and not more than 60 min (including flushing time), once every 2 weeks. The interval between two doses must not be less than 12 days；
FOLFOX4 regimen：D1: Oxaliplatin (OXA) 85 mg/m2 (2-h infusion) + calcium levofolinate (LV) 200 mg/m2 (2-h infusion), followed by 5-fluorouracil (5-Fu) 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion)，D2: LV 200 mg/m2 (2-h infusion), followed by 5-Fu 400 mg/m2 (bolus injection), and 5-Fu 600 mg/m2 (22-h infusion) Once every 2 weeks.
GEMOX Q2W：D1: Gemcitabine (800 mg/m2, 80-min infusion) ，D2: Oxaliplatin (85 mg/m2, 2-h infusion) Once every 2 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
21.4%
6/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
38.2%
13/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
48.9%
45/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Sinus tachycardia
|
3.6%
1/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.5%
6/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Endocrine disorders
Hypothyroidism
|
28.6%
8/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.7%
5/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
15.2%
14/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Endocrine disorders
Hyperthyroidism
|
7.1%
2/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
2/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
4/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Diarrhoea
|
32.1%
9/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
23.5%
8/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
26.1%
24/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal distension
|
17.9%
5/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
29.4%
10/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
27.2%
25/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.9%
5/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
2/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.3%
15/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Vomiting
|
17.9%
5/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.6%
7/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
43.5%
40/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
4/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
29.4%
10/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
28.3%
26/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
4/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
26.5%
9/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
27.2%
25/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
100.0%
3/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Stomatitis
|
14.3%
4/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.6%
7/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.7%
3/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
11.8%
4/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.1%
13/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Ascites
|
10.7%
3/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.6%
7/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.0%
11/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.7%
3/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.6%
7/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
10.7%
3/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.5%
6/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
7.1%
2/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Mouth ulceration
|
7.1%
2/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
4/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
7.1%
2/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Asthenia
|
35.7%
10/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
26.5%
9/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
35.9%
33/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pyrexia
|
32.1%
9/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
29.4%
10/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
60.9%
56/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Chest discomfort
|
10.7%
3/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
4/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Face oedema
|
7.1%
2/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.7%
8/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Oedema peripheral
|
3.6%
1/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
2/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.9%
10/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Reactive capillary endothelial proliferation
|
21.4%
6/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
76.5%
26/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
62.0%
57/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
100.0%
3/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Aspartate aminotransferase increased
|
82.1%
23/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
64.7%
22/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
57.6%
53/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Platelet count decreased
|
78.6%
22/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
88.2%
30/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
53.3%
49/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Bilirubin conjugated increased
|
71.4%
20/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
44.1%
15/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
19.6%
18/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood bilirubin increased
|
67.9%
19/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
47.1%
16/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
30.4%
28/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
White blood cell count decreased
|
64.3%
18/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
88.2%
30/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
53.3%
49/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
100.0%
3/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Neutrophil count decreased
|
60.7%
17/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
85.3%
29/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
47.8%
44/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
100.0%
3/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Alanine aminotransferase increased
|
53.6%
15/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
41.2%
14/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
46.7%
43/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Gamma-glutamyltransferase increased
|
35.7%
10/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
29.4%
10/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
40.2%
37/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Weight decreased
|
35.7%
10/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
17.6%
6/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
22.8%
21/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood lactate dehydrogenase increased
|
25.0%
7/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
23.5%
8/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.3%
15/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood alkaline phosphatase increased
|
21.4%
6/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
38.2%
13/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
38.0%
35/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Haemoglobin decreased
|
17.9%
5/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
2/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.6%
7/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Weight increased
|
17.9%
5/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.6%
7/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.7%
8/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood albumin decreased
|
14.3%
4/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.7%
5/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.5%
6/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood bilirubin unconjugated increased
|
14.3%
4/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
2/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.3%
3/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
14.3%
4/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Amylase increased
|
10.7%
3/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.6%
7/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.9%
10/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Hepatitis B DNA increased
|
10.7%
3/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Lipase increased
|
10.7%
3/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
26.5%
9/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.7%
19/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Albumin globulin ratio decreased
|
7.1%
2/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
2/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.3%
3/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood creatinine increased
|
7.1%
2/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.9%
10/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood glucose increased
|
7.1%
2/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
2/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
4/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood pressure increased
|
7.1%
2/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.4%
5/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Urobilinogen urine increased
|
7.1%
2/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood potassium decreased
|
3.6%
1/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
2/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
4/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Neutrophil count increased
|
3.6%
1/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.7%
8/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Red blood cell count decreased
|
3.6%
1/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.8%
3/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.4%
5/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
White blood cell count increased
|
3.6%
1/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.9%
10/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
39.3%
11/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
44.1%
15/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
35.9%
33/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
32.1%
9/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
44.1%
15/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
44.6%
41/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
28.6%
8/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.6%
7/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
29.3%
27/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
25.0%
7/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
35.3%
12/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
15.2%
14/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
21.4%
6/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.4%
5/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
4/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.8%
3/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.7%
19/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
14.3%
4/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.4%
5/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.1%
2/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.9%
10/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.6%
8/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.8%
3/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
4/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
7/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.4%
6/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
11.8%
4/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.7%
8/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Headache
|
17.9%
5/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dizziness
|
10.7%
3/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.8%
3/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.5%
6/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Hypoaesthesia
|
3.6%
1/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.6%
7/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.5%
6/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Insomnia
|
10.7%
3/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.6%
7/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Proteinuria
|
50.0%
14/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.6%
7/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.1%
13/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Haematuria
|
17.9%
5/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
11.8%
4/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.5%
6/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
7.1%
2/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.4%
6/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.8%
3/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.5%
6/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
2/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.3%
3/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.1%
2/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
2/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.6%
1/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.7%
5/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.6%
1/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.5%
6/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.6%
1/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.4%
5/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
39.3%
11/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
4/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
11.8%
4/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.0%
11/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
4/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.7%
5/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.9%
10/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hypertension
|
78.6%
22/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.8%
3/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
2/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
2/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Influenza like illness
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
2/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.3%
3/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Chills
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.0%
11/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Temperature intolerance
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.4%
5/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
17.6%
6/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
15.2%
14/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.8%
3/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.6%
7/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
2/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.6%
7/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.8%
3/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Total bile acids increased
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.6%
7/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Myoglobin blood increased
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Neutrophil percentage decreased
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
2/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
2/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.2%
2/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
1/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.5%
6/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.8%
3/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Dysphoria
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Adnexa uteri mass
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.8%
3/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.3%
4/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
2/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.5%
6/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/28 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
2/34 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.1%
1/92 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • Up to approximately 4 years
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER