Trial Outcomes & Findings for An Ovarian, Primary Peritoneal or Fallopian Tube Cancer Study for Patients That Have Not Received Prior Chemotherapy (NCT NCT00191646)
NCT ID: NCT00191646
Last Updated: 2011-03-04
Results Overview
Progression free survival was defined as the duration from the date of randomization to the first date of documented disease progression or death from any cause. Tumor assessments were performed every three 21-day cycles during induction and crossover. Progression free survival was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
919 participants
Primary outcome timeframe
Baseline to measured progressive disease or death up to 82 months
Results posted on
2011-03-04
Participant Flow
919 patients were randomized, only 831 randomized patients were included in any analyses. 85 randomized patients were excluded due to significant noncompliant issues and 3 patients were excluded due to unavailable data.
Participant milestones
| Measure |
Gemcitabine/Carboplatin
Induction: Gemcitabine 1000 mg/m\^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.
Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m\^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).
Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m\^2 day 1 to be repeated every 21 days.
|
Paclitaxel/Carboplatin
Induction: Paclitaxel 175 mg/m\^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m\^2 IVPB, 3 hours every 28 days for 12 cycles (one year).
Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m\^2 days 1, 8 to be repeated every 21 days.
|
|---|---|---|
|
Overall Study
STARTED
|
417
|
414
|
|
Overall Study
Received Induction Therapy
|
411
|
409
|
|
Overall Study
Received Consolidation Therapy
|
169
|
183
|
|
Overall Study
Received Crossover Therapy
|
77
|
78
|
|
Overall Study
COMPLETED
|
246
|
261
|
|
Overall Study
NOT COMPLETED
|
171
|
153
|
Reasons for withdrawal
| Measure |
Gemcitabine/Carboplatin
Induction: Gemcitabine 1000 mg/m\^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.
Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m\^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).
Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m\^2 day 1 to be repeated every 21 days.
|
Paclitaxel/Carboplatin
Induction: Paclitaxel 175 mg/m\^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m\^2 IVPB, 3 hours every 28 days for 12 cycles (one year).
Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m\^2 days 1, 8 to be repeated every 21 days.
|
|---|---|---|
|
Overall Study
Toxicity
|
26
|
37
|
|
Overall Study
Disease Progression
|
5
|
6
|
|
Overall Study
Physician Decision
|
20
|
11
|
|
Overall Study
Withdrawal by Subject
|
58
|
39
|
|
Overall Study
Protocol Violation
|
5
|
7
|
|
Overall Study
Death
|
6
|
8
|
|
Overall Study
Other
|
33
|
34
|
|
Overall Study
Missing Data
|
18
|
11
|
Baseline Characteristics
An Ovarian, Primary Peritoneal or Fallopian Tube Cancer Study for Patients That Have Not Received Prior Chemotherapy
Baseline characteristics by cohort
| Measure |
Gemcitabine/Carboplatin
n=417 Participants
Induction: Gemcitabine 1000 mg/m\^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.
Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m\^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).
Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m\^2 day 1 to be repeated every 21 days.
|
Paclitaxel/Carboplatin
n=414 Participants
Induction: Paclitaxel 175 mg/m\^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m\^2 IVPB, 3 hours every 28 days for 12 cycles (one year).
Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m\^2 days 1, 8 to be repeated every 21 days.
|
Total
n=831 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.7 years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
60.3 years
STANDARD_DEVIATION 10.8 • n=107 Participants
|
60.0 years
STANDARD_DEVIATION 11.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
417 Participants
n=99 Participants
|
414 Participants
n=107 Participants
|
831 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
379 participants
n=99 Participants
|
379 participants
n=107 Participants
|
758 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 participants
n=99 Participants
|
13 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native American
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
19 participants
n=99 Participants
|
16 participants
n=107 Participants
|
35 participants
n=206 Participants
|
|
Organ of Origin
Ovary
|
355 participants
n=99 Participants
|
362 participants
n=107 Participants
|
717 participants
n=206 Participants
|
|
Organ of Origin
Peritoneum
|
56 participants
n=99 Participants
|
50 participants
n=107 Participants
|
106 participants
n=206 Participants
|
|
Organ of Origin
Missing Data
|
6 participants
n=99 Participants
|
2 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Extent of Residual Disease
Measurable
|
139 participants
n=99 Participants
|
114 participants
n=107 Participants
|
253 participants
n=206 Participants
|
|
Extent of Residual Disease
Non-measurable
|
276 participants
n=99 Participants
|
300 participants
n=107 Participants
|
576 participants
n=206 Participants
|
|
Extent of Residual Disease
Missing Data
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Zubrod Performance Status
0
|
239 participants
n=99 Participants
|
232 participants
n=107 Participants
|
471 participants
n=206 Participants
|
|
Zubrod Performance Status
1
|
139 participants
n=99 Participants
|
157 participants
n=107 Participants
|
296 participants
n=206 Participants
|
|
Zubrod Performance Status
2
|
27 participants
n=99 Participants
|
16 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
Zubrod Performance Status
>= 3
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Zubrod Performance Status
Missing Data
|
12 participants
n=99 Participants
|
9 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) Stage at Initial Surgery
Stage Ic
|
21 participants
n=99 Participants
|
22 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) Stage at Initial Surgery
Stage II
|
44 participants
n=99 Participants
|
39 participants
n=107 Participants
|
83 participants
n=206 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) Stage at Initial Surgery
Stage III
|
284 participants
n=99 Participants
|
289 participants
n=107 Participants
|
573 participants
n=206 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) Stage at Initial Surgery
Stage IV
|
68 participants
n=99 Participants
|
63 participants
n=107 Participants
|
131 participants
n=206 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) Stage at Initial Surgery
Missing Data
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Histology
Mucinous
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Histology
Serous
|
283 participants
n=99 Participants
|
276 participants
n=107 Participants
|
559 participants
n=206 Participants
|
|
Histology
Endometroid
|
44 participants
n=99 Participants
|
40 participants
n=107 Participants
|
84 participants
n=206 Participants
|
|
Histology
Undifferentiated
|
7 participants
n=99 Participants
|
7 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Histology
Clear Cell
|
21 participants
n=99 Participants
|
23 participants
n=107 Participants
|
44 participants
n=206 Participants
|
|
Histology
Mixed Epithelial
|
9 participants
n=99 Participants
|
13 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Histology
Transitional Cell
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Histology
Malignant Brenner's Tumor
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Histology
Adenocarcinoma Not Otherwise Specified (NOS)
|
22 participants
n=99 Participants
|
23 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
Histology
Other
|
17 participants
n=99 Participants
|
21 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Histology
Missing Data
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Volume of Residual Tumor Following Debulking Surgery
< 2 centimeters
|
309 participants
n=99 Participants
|
314 participants
n=107 Participants
|
623 participants
n=206 Participants
|
|
Volume of Residual Tumor Following Debulking Surgery
>= 2 centimeters
|
102 participants
n=99 Participants
|
96 participants
n=107 Participants
|
198 participants
n=206 Participants
|
|
Volume of Residual Tumor Following Debulking Surgery
Missing Data
|
6 participants
n=99 Participants
|
4 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
CA-125 Units per milliliter at Baseline for All Patients
|
492.772 units per milliliter
STANDARD_DEVIATION 1138.556 • n=99 Participants
|
479.854 units per milliliter
STANDARD_DEVIATION 1117.040 • n=107 Participants
|
486.329 units per milliliter
STANDARD_DEVIATION 1127.213 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to measured progressive disease or death up to 82 monthsPopulation: Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 292 events, 122 censored. P/C Arm: 279 events, 134 censored.
Progression free survival was defined as the duration from the date of randomization to the first date of documented disease progression or death from any cause. Tumor assessments were performed every three 21-day cycles during induction and crossover. Progression free survival was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.
Outcome measures
| Measure |
Gemcitabine/Carboplatin
n=414 Participants
Induction: Gemcitabine 1000 mg/m\^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.
Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m\^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).
Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m\^2 day 1 to be repeated every 21 days.
|
Paclitaxel/Carboplatin
n=413 Participants
Induction: Paclitaxel 175 mg/m\^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m\^2 IVPB, 3 hours every 28 days for 12 cycles (one year).
Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m\^2 days 1, 8 to be repeated every 21 days.
|
Gemcitabine (Crossover)
Crossover (From Paclitaxel to Gemcitabine) - If no complete response on Paclitaxel, patient crossed over to receive Gemcitabine 1000 mg/m\^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity
|
Paclitaxel (Crossover)
Crossover (From Gemcitabine to Paclitaxel) - If no complete response on Gemcitabine, patient crossed over to receive Paclitaxel 175 mg/m\^2, IV, day 1, q 21 days until complete response, disease progression or unacceptable toxicity
|
|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
20.0 Months
Interval 17.9 to 22.2
|
22.2 Months
Interval 19.0 to 25.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to measured progressive disease up to 82 monthsPopulation: All ITT participants with measurable disease at baseline (screening) for induction period; all ITT participants who crossed over to single agent therapy and had measurable disease before or at crossover for crossover period. Participants in consolidation therapy achieved CR during induction therapy and were not included in analysis.
Response rate (RR) = proportion of participants with best overall Complete Response (CR: disappearance of all target lesions \[TL\]) or Partial Response (PR: 30% decrease in sum of longest diameter of TL). Induction therapy RR = number of participants with CR or PR during induction divided by number of participants with measurable disease at baseline (TL measurement during screening). Crossover therapy RR = number of participants with CR or PR during crossover divided by number of participants with measurable disease at baseline (latest TL measurement by first dose date of crossover therapy).
Outcome measures
| Measure |
Gemcitabine/Carboplatin
n=139 Participants
Induction: Gemcitabine 1000 mg/m\^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.
Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m\^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).
Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m\^2 day 1 to be repeated every 21 days.
|
Paclitaxel/Carboplatin
n=114 Participants
Induction: Paclitaxel 175 mg/m\^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m\^2 IVPB, 3 hours every 28 days for 12 cycles (one year).
Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m\^2 days 1, 8 to be repeated every 21 days.
|
Gemcitabine (Crossover)
n=28 Participants
Crossover (From Paclitaxel to Gemcitabine) - If no complete response on Paclitaxel, patient crossed over to receive Gemcitabine 1000 mg/m\^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity
|
Paclitaxel (Crossover)
n=33 Participants
Crossover (From Gemcitabine to Paclitaxel) - If no complete response on Gemcitabine, patient crossed over to receive Paclitaxel 175 mg/m\^2, IV, day 1, q 21 days until complete response, disease progression or unacceptable toxicity
|
|---|---|---|---|---|
|
Proportion of Participants With Response (Response Rate)
|
0.676 proportion of responders
Interval 0.638 to 0.798
|
0.711 proportion of responders
Interval 0.651 to 0.822
|
0.357 proportion of responders
Interval 0.194 to 0.576
|
0.303 proportion of responders
Interval 0.161 to 0.5
|
SECONDARY outcome
Timeframe: Baseline to stopping treatment up to 82 monthsPopulation: Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 336 events, 78 censored. P/C Arm: 330 events, 83 censored.
Time to treatment failure was defined as the duration from date of randomization to the date of the first of the following events: early discontinuation of study therapy; progression of disease, or death due to any cause. Time to treatment failure will be censored at the date of the last follow-up visit for participants who did not discontinue early, who are still alive, and who have not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.
Outcome measures
| Measure |
Gemcitabine/Carboplatin
n=414 Participants
Induction: Gemcitabine 1000 mg/m\^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.
Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m\^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).
Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m\^2 day 1 to be repeated every 21 days.
|
Paclitaxel/Carboplatin
n=413 Participants
Induction: Paclitaxel 175 mg/m\^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m\^2 IVPB, 3 hours every 28 days for 12 cycles (one year).
Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m\^2 days 1, 8 to be repeated every 21 days.
|
Gemcitabine (Crossover)
Crossover (From Paclitaxel to Gemcitabine) - If no complete response on Paclitaxel, patient crossed over to receive Gemcitabine 1000 mg/m\^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity
|
Paclitaxel (Crossover)
Crossover (From Gemcitabine to Paclitaxel) - If no complete response on Gemcitabine, patient crossed over to receive Paclitaxel 175 mg/m\^2, IV, day 1, q 21 days until complete response, disease progression or unacceptable toxicity
|
|---|---|---|---|---|
|
Time to Treatment Failure
|
13.0 months
Interval 11.7 to 15.1
|
13.1 months
Interval 11.4 to 14.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to death from any cause up to 82 monthsPopulation: Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 194 events, 220 censored. P/C Arm: 159 events, 254 censored.
Overall survival is defined as the duration from baseline to death. For participants who are still alive at the data cut-off date, survival will be censored at the last contact date. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.
Outcome measures
| Measure |
Gemcitabine/Carboplatin
n=414 Participants
Induction: Gemcitabine 1000 mg/m\^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.
Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m\^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).
Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m\^2 day 1 to be repeated every 21 days.
|
Paclitaxel/Carboplatin
n=413 Participants
Induction: Paclitaxel 175 mg/m\^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m\^2 IVPB, 3 hours every 28 days for 12 cycles (one year).
Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m\^2 days 1, 8 to be repeated every 21 days.
|
Gemcitabine (Crossover)
Crossover (From Paclitaxel to Gemcitabine) - If no complete response on Paclitaxel, patient crossed over to receive Gemcitabine 1000 mg/m\^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity
|
Paclitaxel (Crossover)
Crossover (From Gemcitabine to Paclitaxel) - If no complete response on Gemcitabine, patient crossed over to receive Paclitaxel 175 mg/m\^2, IV, day 1, q 21 days until complete response, disease progression or unacceptable toxicity
|
|---|---|---|---|---|
|
Overall Survival
|
43.8 months
Interval 38.8 to 48.4
|
57.3 months
Interval 48.5 to 64.0
|
—
|
—
|
Adverse Events
Gemcitabine/Carboplatin Induction
Serious events: 96 serious events
Other events: 404 other events
Deaths: 0 deaths
Paclitaxel/Carboplatin Induction
Serious events: 72 serious events
Other events: 394 other events
Deaths: 0 deaths
Consolidation (Gemcitabine to Paclitaxel)
Serious events: 14 serious events
Other events: 157 other events
Deaths: 0 deaths
Consolidation (Paclitaxel to Paclitaxel)
Serious events: 12 serious events
Other events: 170 other events
Deaths: 0 deaths
Crossover (Paclitaxel to Gemcitabine)
Serious events: 8 serious events
Other events: 76 other events
Deaths: 0 deaths
Crossover (Gemcitabine to Paclitaxel)
Serious events: 8 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine/Carboplatin Induction
n=412 participants at risk
Gemcitabine 1000 milligrams per meter square (mg/m2) Day 1, Day 8, Carboplatin AUC 5 Day 1, 6 21 day cycles
|
Paclitaxel/Carboplatin Induction
n=408 participants at risk
Paclitaxel 175 milligrams per meter square (mg/m2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, 6 21 day cycles
|
Consolidation (Gemcitabine to Paclitaxel)
n=169 participants at risk
Paclitaxel 135mg/m2 IV/3 hours every 28 days for 12 cycles (one year).
|
Consolidation (Paclitaxel to Paclitaxel)
n=183 participants at risk
Paclitaxel 135mg/m2 IV/3 hours every 28 days for 12 cycles (one year).
|
Crossover (Paclitaxel to Gemcitabine)
n=78 participants at risk
Single agent Gemcitabine 1000mg/m2 IV, Day 1, Day 8 to be repeated every 21 days.
|
Crossover (Gemcitabine to Paclitaxel)
n=77 participants at risk
Single agent Paclitaxel 175mg/m2 IV Day 1 to be repeated every 21 days.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
6/412 • Number of events 7
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.2%
5/408 • Number of events 6
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.59%
1/169 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.1%
2/183 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Platelets
|
10.4%
43/412 • Number of events 53
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.2%
5/408 • Number of events 5
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Constipation
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.74%
3/408 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.59%
1/169 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.55%
1/183 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Cardiac disorders
Tachycardia
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.49%
2/412 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.2%
5/412 • Number of events 5
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.2%
9/408 • Number of events 11
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/78 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.74%
3/408 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.97%
4/412 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Cardiac disorders
Atrial fibrillation
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.55%
1/183 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.59%
1/169 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.74%
3/408 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.2%
2/169 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.59%
1/169 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.55%
1/183 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Haematochezia
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.59%
1/169 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.59%
1/169 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.98%
4/408 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/78 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
12/412 • Number of events 16
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.0%
8/408 • Number of events 8
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Retroperitoneum cyst
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.98%
4/408 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.2%
2/169 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.55%
1/183 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
10/412 • Number of events 13
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.2%
9/408 • Number of events 10
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.59%
1/169 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/78 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
General disorders
Chest pain
|
0.49%
2/412 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.74%
3/408 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.59%
1/169 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
General disorders
Chills
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
General disorders
Disease progression
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
General disorders
Fatigue
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
General disorders
Infusion related reaction
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
General disorders
Pain
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.2%
2/169 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
General disorders
Pyrexia
|
1.9%
8/412 • Number of events 10
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.49%
2/408 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.6%
2/78 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
General disorders
Sensation of pressure
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Hepatobiliary disorders
Cholangitis
|
0.24%
1/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Hepatobiliary disorders
Hepatitis
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.55%
1/183 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Immune system disorders
Drug hypersensitivity
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.49%
2/408 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.59%
1/169 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Catheter bacteraemia
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Catheter related infection
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Catheter sepsis
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Cellulitis
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Central line infection
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Clostridial infection
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Diverticulitis
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Empyema
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Neutropenic sepsis
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Pneumonia
|
0.73%
3/412 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.49%
2/408 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.2%
2/169 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.55%
1/183 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/78 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Pneumonia primary atypical
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Postoperative wound infection
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Sepsis
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.74%
3/408 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Sepsis syndrome
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Thrombophlebitis septic
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.59%
1/169 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
6/412 • Number of events 9
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.98%
4/408 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Viral infection
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Wound infection
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.55%
1/183 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Injury, poisoning and procedural complications
Drug administration error
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/78 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.59%
1/169 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.55%
1/183 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/78 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Absolute neutrophil count/absolute granulocyte count
|
5.1%
21/412 • Number of events 24
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.4%
14/408 • Number of events 16
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.59%
1/169 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.55%
1/183 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/78 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Blood creatinine increased
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Body temperature increased
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Haematocrit
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Hemoglobin
|
5.8%
24/412 • Number of events 28
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.74%
3/408 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/78 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/78 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Platelet count
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
White blood cells
|
2.4%
10/412 • Number of events 12
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.74%
3/408 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.55%
1/183 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Weight decreased
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
6/412 • Number of events 6
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.7%
7/408 • Number of events 8
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/78 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.49%
2/408 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.49%
2/408 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.74%
3/408 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.59%
1/169 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.55%
1/183 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Nervous system disorders
Dizziness
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/78 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Nervous system disorders
Syncope
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.59%
1/169 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Hematologic
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Infection/febrile neutropenia
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Psychiatric disorders
Mental status changes
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Renal and urinary disorders
Costovertebral angle tenderness
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.74%
3/408 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Renal and urinary disorders
Renal failure acute
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Renal and urinary disorders
Renal infarct
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/78 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.49%
2/408 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.73%
3/412 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.49%
2/408 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.73%
3/412 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/78 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.2%
5/408 • Number of events 5
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.55%
1/183 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.55%
1/183 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.55%
1/183 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Surgical and medical procedures
Hospitalisation
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.74%
3/408 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Surgical and medical procedures
Pain management
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.55%
1/183 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Vascular disorders
Deep vein thrombosis
|
1.5%
6/412 • Number of events 6
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.74%
3/408 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.55%
1/183 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Vascular disorders
Haemorrhage
|
0.24%
1/412 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Vascular disorders
Hypotension
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.55%
1/183 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/408
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/412
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
Other adverse events
| Measure |
Gemcitabine/Carboplatin Induction
n=412 participants at risk
Gemcitabine 1000 milligrams per meter square (mg/m2) Day 1, Day 8, Carboplatin AUC 5 Day 1, 6 21 day cycles
|
Paclitaxel/Carboplatin Induction
n=408 participants at risk
Paclitaxel 175 milligrams per meter square (mg/m2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, 6 21 day cycles
|
Consolidation (Gemcitabine to Paclitaxel)
n=169 participants at risk
Paclitaxel 135mg/m2 IV/3 hours every 28 days for 12 cycles (one year).
|
Consolidation (Paclitaxel to Paclitaxel)
n=183 participants at risk
Paclitaxel 135mg/m2 IV/3 hours every 28 days for 12 cycles (one year).
|
Crossover (Paclitaxel to Gemcitabine)
n=78 participants at risk
Single agent Gemcitabine 1000mg/m2 IV, Day 1, Day 8 to be repeated every 21 days.
|
Crossover (Gemcitabine to Paclitaxel)
n=77 participants at risk
Single agent Paclitaxel 175mg/m2 IV Day 1 to be repeated every 21 days.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.2%
9/412 • Number of events 25
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.5%
10/408 • Number of events 25
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.2%
2/169 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.2%
4/183 • Number of events 9
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.1%
4/78 • Number of events 10
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
22/412 • Number of events 68
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.0%
8/408 • Number of events 12
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.59%
1/169 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.55%
1/183 • Number of events 7
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.1%
4/78 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Ear and labyrinth disorders
Tinnitus
|
4.4%
18/412 • Number of events 31
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.4%
22/408 • Number of events 39
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.7%
8/169 • Number of events 26
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
7.7%
14/183 • Number of events 39
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.6%
2/77 • Number of events 8
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Eye disorders
Vision blurred
|
3.6%
15/412 • Number of events 26
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.4%
26/408 • Number of events 50
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.3%
9/169 • Number of events 26
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
8.2%
15/183 • Number of events 33
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.8%
3/78 • Number of events 6
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.6%
2/77 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Eye disorders
Visual disturbance
|
1.2%
5/412 • Number of events 5
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.7%
11/408 • Number of events 15
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.7%
8/169 • Number of events 15
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.4%
8/183 • Number of events 23
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.8%
3/78 • Number of events 5
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.2%
4/77 • Number of events 9
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.1%
21/412 • Number of events 32
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.7%
11/408 • Number of events 16
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.3%
9/169 • Number of events 24
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
7.1%
13/183 • Number of events 18
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.4%
5/78 • Number of events 12
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.5%
5/77 • Number of events 10
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Abdominal pain
|
21.4%
88/412 • Number of events 168
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
22.5%
92/408 • Number of events 148
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
17.2%
29/169 • Number of events 76
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
17.5%
32/183 • Number of events 68
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
17.9%
14/78 • Number of events 26
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
20.8%
16/77 • Number of events 30
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.1%
21/412 • Number of events 27
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.9%
16/408 • Number of events 24
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.7%
8/169 • Number of events 13
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.8%
7/183 • Number of events 10
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.6%
2/78 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.2%
4/77 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Constipation
|
42.0%
173/412 • Number of events 400
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
41.7%
170/408 • Number of events 391
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
32.0%
54/169 • Number of events 154
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
33.9%
62/183 • Number of events 178
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
39.7%
31/78 • Number of events 66
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
32.5%
25/77 • Number of events 60
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.1%
83/412 • Number of events 145
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
23.8%
97/408 • Number of events 187
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
25.4%
43/169 • Number of events 107
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
23.5%
43/183 • Number of events 111
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
15.4%
12/78 • Number of events 17
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
11.7%
9/77 • Number of events 19
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.9%
16/412 • Number of events 21
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.2%
17/408 • Number of events 26
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.3%
9/169 • Number of events 24
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
7.7%
14/183 • Number of events 20
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.8%
3/78 • Number of events 6
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.5%
5/77 • Number of events 6
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Nausea
|
51.7%
213/412 • Number of events 504
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
50.2%
205/408 • Number of events 506
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
39.6%
67/169 • Number of events 191
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
25.1%
46/183 • Number of events 110
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
41.0%
32/78 • Number of events 67
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
27.3%
21/77 • Number of events 48
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Stomatitis
|
6.1%
25/412 • Number of events 33
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.6%
23/408 • Number of events 40
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.5%
11/169 • Number of events 18
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.4%
8/183 • Number of events 24
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.9%
3/77 • Number of events 7
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
95/412 • Number of events 146
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
23.3%
95/408 • Number of events 154
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
11.2%
19/169 • Number of events 24
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.6%
12/183 • Number of events 20
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
17.9%
14/78 • Number of events 22
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
11.7%
9/77 • Number of events 20
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
General disorders
Asthenia
|
6.8%
28/412 • Number of events 39
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
8.3%
34/408 • Number of events 41
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.1%
7/169 • Number of events 12
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.4%
8/183 • Number of events 15
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.8%
3/78 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.6%
2/77 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
General disorders
Fatigue
|
68.2%
281/412 • Number of events 948
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
68.4%
279/408 • Number of events 912
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
63.9%
108/169 • Number of events 531
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
65.0%
119/183 • Number of events 558
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
71.8%
56/78 • Number of events 217
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
51.9%
40/77 • Number of events 160
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
General disorders
Oedema
|
4.9%
20/412 • Number of events 31
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.0%
8/408 • Number of events 13
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.8%
3/169 • Number of events 5
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.4%
8/183 • Number of events 18
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.4%
5/78 • Number of events 7
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
General disorders
Oedema peripheral
|
11.2%
46/412 • Number of events 84
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
8.1%
33/408 • Number of events 53
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
10.7%
18/169 • Number of events 50
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
11.5%
21/183 • Number of events 64
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.4%
5/78 • Number of events 12
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
7.8%
6/77 • Number of events 8
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
General disorders
Pain
|
6.1%
25/412 • Number of events 31
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
9.3%
38/408 • Number of events 59
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
21.3%
36/169 • Number of events 76
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
14.2%
26/183 • Number of events 43
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
10.3%
8/78 • Number of events 12
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.2%
4/77 • Number of events 6
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
General disorders
Pyrexia
|
8.3%
34/412 • Number of events 47
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.7%
19/408 • Number of events 24
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.4%
4/169 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.3%
6/183 • Number of events 8
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
11.5%
9/78 • Number of events 10
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.2%
4/77 • Number of events 5
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
5/412 • Number of events 5
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.2%
5/408 • Number of events 7
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.0%
5/169 • Number of events 7
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.3%
6/183 • Number of events 6
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.1%
4/78 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Sinusitis
|
1.5%
6/412 • Number of events 6
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.2%
13/408 • Number of events 18
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.8%
3/169 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.5%
10/183 • Number of events 14
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
9.0%
7/78 • Number of events 8
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
12/412 • Number of events 12
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.5%
6/408 • Number of events 8
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.1%
7/169 • Number of events 10
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.6%
12/183 • Number of events 13
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.1%
4/78 • Number of events 5
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Infections and infestations
Urinary tract infection
|
6.8%
28/412 • Number of events 31
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
7.6%
31/408 • Number of events 41
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.9%
10/169 • Number of events 15
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
7.7%
14/183 • Number of events 19
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.1%
4/78 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.2%
4/77 • Number of events 5
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.5%
31/412 • Number of events 48
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.7%
15/408 • Number of events 28
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.3%
9/169 • Number of events 12
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.3%
6/183 • Number of events 19
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Alanine aminotransferase
|
5.8%
24/412 • Number of events 53
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.7%
19/408 • Number of events 33
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.4%
4/169 • Number of events 6
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.8%
7/183 • Number of events 21
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.4%
5/78 • Number of events 12
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Alanine aminotransferase increased
|
15.5%
64/412 • Number of events 120
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.6%
27/408 • Number of events 46
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.9%
10/169 • Number of events 27
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.5%
10/183 • Number of events 17
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
14.1%
11/78 • Number of events 20
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.6%
2/77 • Number of events 10
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Anc/agc
|
91.7%
378/412 • Number of events 1638
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
88.5%
361/408 • Number of events 1531
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
52.1%
88/169 • Number of events 314
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
50.8%
93/183 • Number of events 325
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
87.2%
68/78 • Number of events 246
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
61.0%
47/77 • Number of events 173
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Aspartate aminotransferase increased
|
14.1%
58/412 • Number of events 100
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.1%
21/408 • Number of events 36
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.9%
10/169 • Number of events 21
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
7.1%
13/183 • Number of events 23
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
15.4%
12/78 • Number of events 19
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.9%
3/77 • Number of events 8
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Blood albumin decreased
|
4.4%
18/412 • Number of events 39
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.2%
17/408 • Number of events 36
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.2%
2/169 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.6%
3/183 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.1%
4/78 • Number of events 7
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Blood alkaline phosphatase
|
5.6%
23/412 • Number of events 51
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.9%
20/408 • Number of events 32
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.6%
6/169 • Number of events 19
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.8%
7/183 • Number of events 12
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.8%
3/78 • Number of events 7
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Blood alkaline phosphatase increased
|
12.6%
52/412 • Number of events 103
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
9.1%
37/408 • Number of events 68
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
7.7%
13/169 • Number of events 33
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.4%
8/183 • Number of events 38
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
10.3%
8/78 • Number of events 11
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
9.1%
7/77 • Number of events 12
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Blood glucose
|
2.7%
11/412 • Number of events 18
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.4%
22/408 • Number of events 32
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
7.1%
12/169 • Number of events 17
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.5%
10/183 • Number of events 46
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.2%
4/77 • Number of events 10
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Blood glucose increased
|
11.2%
46/412 • Number of events 93
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
12.3%
50/408 • Number of events 108
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
15.4%
26/169 • Number of events 79
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
11.5%
21/183 • Number of events 55
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
12.8%
10/78 • Number of events 13
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.5%
5/77 • Number of events 18
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Blood sodium decreased
|
3.4%
14/412 • Number of events 28
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.6%
23/408 • Number of events 41
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.0%
5/169 • Number of events 7
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.8%
7/183 • Number of events 9
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.4%
5/78 • Number of events 7
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Blood urea increased
|
4.6%
19/412 • Number of events 39
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.4%
18/408 • Number of events 28
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
13.0%
22/169 • Number of events 53
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.8%
7/183 • Number of events 20
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.8%
3/78 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.2%
4/77 • Number of events 21
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Carbon dioxide increased
|
4.4%
18/412 • Number of events 41
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.0%
8/408 • Number of events 11
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
7.1%
12/169 • Number of events 33
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.3%
6/183 • Number of events 11
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.1%
4/78 • Number of events 5
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.6%
2/77 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Haematocrit
|
5.8%
24/412 • Number of events 42
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.2%
17/408 • Number of events 33
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.59%
1/169 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.8%
7/183 • Number of events 12
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/78 • Number of events 9
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Hemoglobin
|
93.4%
385/412 • Number of events 1830
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
86.3%
352/408 • Number of events 1436
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
49.1%
83/169 • Number of events 338
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
56.3%
103/183 • Number of events 375
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
84.6%
66/78 • Number of events 270
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
70.1%
54/77 • Number of events 201
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Hepatic enzyme increased
|
1.2%
5/412 • Number of events 8
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.25%
1/408 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.6%
6/169 • Number of events 9
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.1%
2/183 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.4%
5/78 • Number of events 8
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Liver function test abnormal
|
3.9%
16/412 • Number of events 19
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.2%
9/408 • Number of events 13
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.2%
2/169 • Number of events 12
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.55%
1/183 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.4%
5/78 • Number of events 11
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.6%
2/77 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Platelets
|
92.0%
379/412 • Number of events 1550
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
57.1%
233/408 • Number of events 631
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
21.3%
36/169 • Number of events 110
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
12.6%
23/183 • Number of events 72
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
78.2%
61/78 • Number of events 216
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
20.8%
16/77 • Number of events 31
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Protein total decreased
|
2.2%
9/412 • Number of events 10
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.7%
15/408 • Number of events 20
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.1%
7/169 • Number of events 17
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.55%
1/183 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.4%
5/78 • Number of events 6
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.9%
3/77 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
White blood cells
|
92.2%
380/412 • Number of events 1714
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
85.8%
350/408 • Number of events 1507
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
52.1%
88/169 • Number of events 423
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
55.2%
101/183 • Number of events 442
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
87.2%
68/78 • Number of events 247
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
63.6%
49/77 • Number of events 208
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Weight decreased
|
9.0%
37/412 • Number of events 67
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
7.6%
31/408 • Number of events 45
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.6%
6/169 • Number of events 10
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.3%
6/183 • Number of events 7
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/78 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.9%
3/77 • Number of events 5
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Investigations
Weight increased
|
5.8%
24/412 • Number of events 60
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.7%
15/408 • Number of events 33
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
15.4%
26/169 • Number of events 100
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
16.9%
31/183 • Number of events 88
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
9.0%
7/78 • Number of events 16
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.5%
5/77 • Number of events 25
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Metabolism and nutrition disorders
Anorexia
|
11.9%
49/412 • Number of events 82
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
14.0%
57/408 • Number of events 99
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
7.7%
13/169 • Number of events 22
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.7%
5/183 • Number of events 8
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
9.0%
7/78 • Number of events 15
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
10.4%
8/77 • Number of events 25
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.9%
45/412 • Number of events 111
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
17.6%
72/408 • Number of events 158
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
21.3%
36/169 • Number of events 150
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
23.0%
42/183 • Number of events 152
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
12.8%
10/78 • Number of events 23
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
20.8%
16/77 • Number of events 53
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.1%
17/412 • Number of events 35
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.7%
11/408 • Number of events 18
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/169
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.6%
2/78 • Number of events 7
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.5%
5/77 • Number of events 6
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.4%
14/412 • Number of events 29
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.0%
8/408 • Number of events 12
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.2%
2/169 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.6%
3/183 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.8%
3/78 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.2%
4/77 • Number of events 5
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.0%
29/412 • Number of events 47
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.9%
20/408 • Number of events 29
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.6%
6/169 • Number of events 13
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.0%
11/183 • Number of events 18
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.6%
2/78 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
10.4%
8/77 • Number of events 13
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.4%
14/412 • Number of events 19
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.4%
14/408 • Number of events 24
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.6%
6/169 • Number of events 9
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.4%
8/183 • Number of events 15
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.2%
4/77 • Number of events 7
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.7%
48/412 • Number of events 86
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
26.5%
108/408 • Number of events 247
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
39.1%
66/169 • Number of events 192
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
29.0%
53/183 • Number of events 149
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
20.5%
16/78 • Number of events 32
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
32.5%
25/77 • Number of events 62
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.9%
8/412 • Number of events 16
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.98%
4/408 • Number of events 6
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.4%
4/169 • Number of events 10
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.5%
10/183 • Number of events 33
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.6%
2/78 • Number of events 6
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.4%
47/412 • Number of events 72
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
10.3%
42/408 • Number of events 81
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
11.2%
19/169 • Number of events 37
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
16.4%
30/183 • Number of events 76
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
11.5%
9/78 • Number of events 12
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
10.4%
8/77 • Number of events 12
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.4%
14/412 • Number of events 22
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
8.1%
33/408 • Number of events 45
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
9.5%
16/169 • Number of events 38
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.4%
8/183 • Number of events 15
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/78 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
7.8%
6/77 • Number of events 9
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.6%
15/412 • Number of events 30
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.4%
26/408 • Number of events 46
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.7%
8/169 • Number of events 22
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
9.8%
18/183 • Number of events 69
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.8%
3/78 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.1%
25/412 • Number of events 41
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
13.5%
55/408 • Number of events 97
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
21.9%
37/169 • Number of events 91
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
13.7%
25/183 • Number of events 53
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
10.3%
8/78 • Number of events 17
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
10.4%
8/77 • Number of events 13
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.7%
36/412 • Number of events 62
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
24.5%
100/408 • Number of events 220
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
26.0%
44/169 • Number of events 130
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
20.8%
38/183 • Number of events 103
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
12.8%
10/78 • Number of events 23
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
22.1%
17/77 • Number of events 40
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.6%
27/412 • Number of events 45
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
12.0%
49/408 • Number of events 75
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
10.7%
18/169 • Number of events 45
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
9.8%
18/183 • Number of events 62
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
10.3%
8/78 • Number of events 8
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
7.8%
6/77 • Number of events 6
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Nervous system disorders
Dizziness
|
10.7%
44/412 • Number of events 65
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
8.3%
34/408 • Number of events 52
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.5%
11/169 • Number of events 22
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
7.7%
14/183 • Number of events 18
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
7.7%
6/78 • Number of events 10
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.5%
5/77 • Number of events 9
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Nervous system disorders
Headache
|
9.7%
40/412 • Number of events 82
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
9.6%
39/408 • Number of events 75
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
11.8%
20/169 • Number of events 41
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
8.2%
15/183 • Number of events 28
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.1%
4/78 • Number of events 7
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
7.8%
6/77 • Number of events 14
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Nervous system disorders
Hypoaesthesia
|
6.1%
25/412 • Number of events 36
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
13.0%
53/408 • Number of events 93
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
17.2%
29/169 • Number of events 70
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
18.0%
33/183 • Number of events 103
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.4%
5/78 • Number of events 14
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
15.6%
12/77 • Number of events 32
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Nervous system disorders
Neuropathy
|
3.6%
15/412 • Number of events 28
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
15.9%
65/408 • Number of events 140
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
23.1%
39/169 • Number of events 122
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
27.9%
51/183 • Number of events 183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
9.0%
7/78 • Number of events 20
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
24.7%
19/77 • Number of events 64
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.3%
22/412 • Number of events 58
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
24.3%
99/408 • Number of events 190
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
36.7%
62/169 • Number of events 207
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
37.2%
68/183 • Number of events 211
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
21.8%
17/78 • Number of events 39
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
29.9%
23/77 • Number of events 60
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Nervous system disorders
Paraesthesia
|
6.8%
28/412 • Number of events 42
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
21.6%
88/408 • Number of events 191
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
22.5%
38/169 • Number of events 94
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
23.0%
42/183 • Number of events 165
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
19.2%
15/78 • Number of events 27
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
11.7%
9/77 • Number of events 19
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.9%
20/412 • Number of events 42
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
15.0%
61/408 • Number of events 162
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
15.4%
26/169 • Number of events 91
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
23.5%
43/183 • Number of events 186
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
11.5%
9/78 • Number of events 22
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
14.3%
11/77 • Number of events 48
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Nervous system disorders
Neurology
|
0.49%
2/412 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.5%
10/408 • Number of events 17
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.8%
3/169 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.8%
7/183 • Number of events 28
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/78 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.5%
5/77 • Number of events 20
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Nervous system disorders
Pain
|
1.5%
6/412 • Number of events 7
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.7%
7/408 • Number of events 9
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.59%
1/169 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.6%
3/183 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/78 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.5%
5/77 • Number of events 15
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Psychiatric disorders
Anxiety
|
7.8%
32/412 • Number of events 63
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
8.6%
35/408 • Number of events 50
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
11.2%
19/169 • Number of events 38
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
8.2%
15/183 • Number of events 35
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.1%
4/78 • Number of events 5
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
10.4%
8/77 • Number of events 11
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Psychiatric disorders
Depression
|
11.4%
47/412 • Number of events 92
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
12.3%
50/408 • Number of events 100
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
16.0%
27/169 • Number of events 75
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
19.7%
36/183 • Number of events 132
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.8%
3/78 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
13.0%
10/77 • Number of events 33
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Psychiatric disorders
Insomnia
|
10.2%
42/412 • Number of events 92
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
17.9%
73/408 • Number of events 150
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
18.9%
32/169 • Number of events 99
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
12.6%
23/183 • Number of events 77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
11.5%
9/78 • Number of events 12
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
9.1%
7/77 • Number of events 9
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Renal and urinary disorders
Dysuria
|
4.6%
19/412 • Number of events 25
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.1%
21/408 • Number of events 26
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.6%
6/169 • Number of events 7
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.9%
9/183 • Number of events 11
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.8%
3/78 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.5%
5/77 • Number of events 7
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Renal and urinary disorders
Pollakiuria
|
4.4%
18/412 • Number of events 32
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.4%
22/408 • Number of events 38
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.1%
7/169 • Number of events 9
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.2%
4/183 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.8%
3/78 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.9%
3/77 • Number of events 6
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.73%
3/412 • Number of events 6
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.0%
8/408 • Number of events 12
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.4%
4/169 • Number of events 13
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.5%
10/183 • Number of events 34
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Renal and urinary disorders
Urinary incontinence
|
1.7%
7/412 • Number of events 13
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.4%
22/408 • Number of events 46
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.3%
9/169 • Number of events 20
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.8%
7/183 • Number of events 24
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/78 • Number of events 1
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.9%
3/77 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.0%
37/412 • Number of events 57
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
7.1%
29/408 • Number of events 45
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
13.0%
22/169 • Number of events 49
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
12.6%
23/183 • Number of events 48
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
12.8%
10/78 • Number of events 24
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
6.5%
5/77 • Number of events 21
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.1%
50/412 • Number of events 83
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
16.4%
67/408 • Number of events 99
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
11.2%
19/169 • Number of events 40
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
12.6%
23/183 • Number of events 61
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
14.1%
11/78 • Number of events 14
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
10.4%
8/77 • Number of events 9
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.5%
31/412 • Number of events 55
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.9%
20/408 • Number of events 27
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.3%
9/169 • Number of events 20
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
7.1%
13/183 • Number of events 31
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.1%
4/78 • Number of events 15
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.2%
4/77 • Number of events 8
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.0%
37/412 • Number of events 53
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.2%
13/408 • Number of events 22
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.0%
5/169 • Number of events 6
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/183
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.6%
2/78 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.8%
94/412 • Number of events 260
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
61.0%
249/408 • Number of events 917
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
60.4%
102/169 • Number of events 600
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
51.4%
94/183 • Number of events 469
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
53.8%
42/78 • Number of events 117
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
63.6%
49/77 • Number of events 251
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Skin and subcutaneous tissue disorders
Hypotrichosis
|
5.8%
24/412 • Number of events 73
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.2%
9/408 • Number of events 12
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.2%
2/169 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.1%
2/183 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/78
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
0.00%
0/77
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.4%
18/412 • Number of events 32
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.9%
20/408 • Number of events 33
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.9%
10/169 • Number of events 18
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.4%
8/183 • Number of events 14
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.6%
2/78 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
3.9%
3/77 • Number of events 3
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.2%
42/412 • Number of events 59
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
10.3%
42/408 • Number of events 68
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
17.8%
30/169 • Number of events 50
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
13.7%
25/183 • Number of events 48
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
10.3%
8/78 • Number of events 9
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
10.4%
8/77 • Number of events 12
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Vascular disorders
Flushing
|
1.5%
6/412 • Number of events 9
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
2.7%
11/408 • Number of events 22
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
5.9%
10/169 • Number of events 14
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
4.4%
8/183 • Number of events 34
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/78 • Number of events 4
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
1.3%
1/77 • Number of events 2
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
|
Vascular disorders
Hot flush
|
9.2%
38/412 • Number of events 99
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
14.7%
60/408 • Number of events 145
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
20.7%
35/169 • Number of events 132
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
20.8%
38/183 • Number of events 172
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
14.1%
11/78 • Number of events 31
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
7.8%
6/77 • Number of events 22
A participant was randomized to P/C but treated with G/C, and thus included in the P/C arm ITT population (disposition and efficacy tables) and included in the G/C arm of treated population (AE tables). This results in an inconsistency between number of participants analyzed and participant flow module.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60