Trial Outcomes & Findings for Dose-response Study of Sodium Nitroprusside in Children Requiring Controlled Hypotension in the Operating Room (NCT NCT00135668)
NCT ID: NCT00135668
Last Updated: 2024-01-02
Results Overview
From the Baseline MAP until the end of the blinded phase; scheduled for 30 min
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
211 participants
Primary outcome timeframe
Approximately 30 minutes
Results posted on
2024-01-02
Participant Flow
206 participants were randomized to be dosed with one of 4 differed SNP infusion rates.
Of the 206 randomized participants, 3 discontinued pre-operatively and 203 participants completed the study and no patients discontinued the study post operative. Participants counted as completing the study may have stopped the blinded study drug period early but continued on to the open-label study drug period and follow-up period.
Participant milestones
| Measure |
0.3 μg/kg/Min
Rate of SNP infusion during blinded study drug period
Patients who were randomized and never received a dose of study drug did not contribute data to any analysis population. The following three analysis populations were included in the study:
Intent-to-Treat Safety (ITT S) Population consisted of all consented and randomized patients who received any amount of study drug
Intent-to-Treat Efficacy Evaluable (ITT E) Population consisted of randomized and treated patients who had a pre treatment Baseline MAP and a second MAP determined within 30 minutes of study drug infusion at the starting dose
Intent-to-Treat Completer (ITT C) Population consisted of all randomized and treated patients who completed the 30-minute blinded study drug period. The ITT C population is indicated by the participants who completed 'period 2.
P
|
1 μg/kg/Min
Rate of SNP infusion during blinded study drug period
Patients who were randomized and never received a dose of study drug did not contribute data to any analysis population. The following three analysis populations were included in the study:
Intent-to-Treat Safety (ITT S) Population consisted of all consented and randomized patients who received any amount of study drug
Intent-to-Treat Efficacy Evaluable (ITT E) Population consisted of randomized and treated patients who had a pre treatment Baseline MAP and a second MAP determined within 30 minutes of study drug infusion at the starting dose
Intent-to-Treat Completer (ITT C) Population consisted of all randomized and treated patients who completed the 30-minute blinded study drug period. The ITT C population is indicated by the participants who completed 'period 2.
.
|
2 μg/kg/Min
Rate of SNP infusion during blinded study drug period
Patients who were randomized and never received a dose of study drug did not contribute data to any analysis population. The following three analysis populations were included in the study:
Intent-to-Treat Safety (ITT S) Population consisted of all consented and randomized patients who received any amount of study drug
Intent-to-Treat Efficacy Evaluable (ITT E) Population consisted of randomized and treated patients who had a pre treatment Baseline MAP and a second MAP determined within 30 minutes of study drug infusion at the starting dose
Intent-to-Treat Completer (ITT C) Population consisted of all randomized and treated patients who completed the 30-minute blinded study drug period. The ITT C population is indicated by the participants who completed 'period 2.
|
3 μg/kg/Min
Rate of SNP infusion during blinded study drug period
Patients who were randomized and never received a dose of study drug did not contribute data to any analysis population. The following three analysis populations were included in the study:
Intent-to-Treat Safety (ITT S) Population consisted of all consented and randomized patients who received any amount of study drug
Intent-to-Treat Efficacy Evaluable (ITT E) Population consisted of randomized and treated patients who had a pre treatment Baseline MAP and a second MAP determined within 30 minutes of study drug infusion at the starting dose
Intent-to-Treat Completer (ITT C) Population consisted of all randomized and treated patients who completed the 30-minute blinded study drug period. The ITT C population is indicated by the participants who completed 'period 2.
|
|---|---|---|---|---|
|
Overall Study - Randomized to be Dosed
STARTED
|
51
|
49
|
55
|
51
|
|
Overall Study - Randomized to be Dosed
COMPLETED
|
50
|
49
|
53
|
51
|
|
Overall Study - Randomized to be Dosed
NOT COMPLETED
|
1
|
0
|
2
|
0
|
|
Blinded Treatment Phase-Randomized/Dosed
STARTED
|
50
|
49
|
53
|
51
|
|
Blinded Treatment Phase-Randomized/Dosed
COMPLETED
|
38
|
23
|
13
|
18
|
|
Blinded Treatment Phase-Randomized/Dosed
NOT COMPLETED
|
12
|
26
|
40
|
33
|
Reasons for withdrawal
| Measure |
0.3 μg/kg/Min
Rate of SNP infusion during blinded study drug period
Patients who were randomized and never received a dose of study drug did not contribute data to any analysis population. The following three analysis populations were included in the study:
Intent-to-Treat Safety (ITT S) Population consisted of all consented and randomized patients who received any amount of study drug
Intent-to-Treat Efficacy Evaluable (ITT E) Population consisted of randomized and treated patients who had a pre treatment Baseline MAP and a second MAP determined within 30 minutes of study drug infusion at the starting dose
Intent-to-Treat Completer (ITT C) Population consisted of all randomized and treated patients who completed the 30-minute blinded study drug period. The ITT C population is indicated by the participants who completed 'period 2.
P
|
1 μg/kg/Min
Rate of SNP infusion during blinded study drug period
Patients who were randomized and never received a dose of study drug did not contribute data to any analysis population. The following three analysis populations were included in the study:
Intent-to-Treat Safety (ITT S) Population consisted of all consented and randomized patients who received any amount of study drug
Intent-to-Treat Efficacy Evaluable (ITT E) Population consisted of randomized and treated patients who had a pre treatment Baseline MAP and a second MAP determined within 30 minutes of study drug infusion at the starting dose
Intent-to-Treat Completer (ITT C) Population consisted of all randomized and treated patients who completed the 30-minute blinded study drug period. The ITT C population is indicated by the participants who completed 'period 2.
.
|
2 μg/kg/Min
Rate of SNP infusion during blinded study drug period
Patients who were randomized and never received a dose of study drug did not contribute data to any analysis population. The following three analysis populations were included in the study:
Intent-to-Treat Safety (ITT S) Population consisted of all consented and randomized patients who received any amount of study drug
Intent-to-Treat Efficacy Evaluable (ITT E) Population consisted of randomized and treated patients who had a pre treatment Baseline MAP and a second MAP determined within 30 minutes of study drug infusion at the starting dose
Intent-to-Treat Completer (ITT C) Population consisted of all randomized and treated patients who completed the 30-minute blinded study drug period. The ITT C population is indicated by the participants who completed 'period 2.
|
3 μg/kg/Min
Rate of SNP infusion during blinded study drug period
Patients who were randomized and never received a dose of study drug did not contribute data to any analysis population. The following three analysis populations were included in the study:
Intent-to-Treat Safety (ITT S) Population consisted of all consented and randomized patients who received any amount of study drug
Intent-to-Treat Efficacy Evaluable (ITT E) Population consisted of randomized and treated patients who had a pre treatment Baseline MAP and a second MAP determined within 30 minutes of study drug infusion at the starting dose
Intent-to-Treat Completer (ITT C) Population consisted of all randomized and treated patients who completed the 30-minute blinded study drug period. The ITT C population is indicated by the participants who completed 'period 2.
|
|---|---|---|---|---|
|
Overall Study - Randomized to be Dosed
Discontinued pre-operatively
|
1
|
0
|
2
|
0
|
Baseline Characteristics
Dose-response Study of Sodium Nitroprusside in Children Requiring Controlled Hypotension in the Operating Room
Baseline characteristics by cohort
| Measure |
0.3 mcg/kg/Min
n=50 Participants
Infusion rate scheduled to be titrated during the blinded phase to 0.3 mcg/kg/min
|
1 mcg/kg/Min
n=49 Participants
Infusion rate scheduled to be titrated during the blinded phase to 1 mcg/kg/min
|
2 mcg/kg/Min
n=53 Participants
Infusion rate scheduled to be titrated during the blinded phase to 2 mcg/kg/min
|
3 mcg/kg/Min
n=51 Participants
Infusion rate scheduled to be titrated during the blinded phase to 3 mcg/kg/min
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
|
110.30 Months
STANDARD_DEVIATION 75.424 • n=93 Participants
|
114.74 Months
STANDARD_DEVIATION 71.479 • n=4 Participants
|
114.21 Months
STANDARD_DEVIATION 73.864 • n=27 Participants
|
111.30 Months
STANDARD_DEVIATION 76.429 • n=483 Participants
|
112.64 Months
STANDARD_DEVIATION 73.610 • n=36 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
74 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
32 Participants
n=483 Participants
|
129 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
47 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
38 Participants
n=483 Participants
|
156 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Approximately 30 minutesPopulation: Change from Baseline in MAP across the Sodium Nitroprusside (SNP) dose groups by mean at Baseline, 30 mins (LOCF), and change from Baseline for the ITT Efficacy Evaluable Population consisted of randomized and treated patients who had a pre-treatment Baseline MAP and a second MAP determined within 30 mins of study drug infusion at the starting dose
From the Baseline MAP until the end of the blinded phase; scheduled for 30 min
Outcome measures
| Measure |
0.3 mcg/kg/Min
n=50 Participants
Rate of SNP infusion during blinded study drug period
|
1 mcg/kg/Min
n=49 Participants
Rate of SNP infusion during blinded study drug period
|
2 mcg/kg/Min
n=53 Participants
Rate of SNP infusion during blinded study drug period
|
3 mcg/kg/Min
n=51 Participants
Rate of SNP infusion during blinded study drug period
|
Total
n=203 Participants
Total result
|
|---|---|---|---|---|---|
|
Change in Mean Arterial Pressure (MAP) From the Baseline MAP
Change from Baseline
|
-11.0 mm Hg
Standard Deviation 15.68
|
-17.0 mm Hg
Standard Deviation 12.88
|
-20.0 mm Hg
Standard Deviation 15.95
|
-16.6 mm Hg
Standard Deviation 18.63
|
-16.2 mm Hg
Standard Deviation 16.16
|
|
Change in Mean Arterial Pressure (MAP) From the Baseline MAP
Baseline Observed
|
76.3 mm Hg
Standard Deviation 11.37
|
76.9 mm Hg
Standard Deviation 14.5
|
73.5 mm Hg
Standard Deviation 11.5
|
76.3 mm Hg
Standard Deviation 12.06
|
75.7 mm Hg
Standard Deviation 12.37
|
|
Change in Mean Arterial Pressure (MAP) From the Baseline MAP
30 Minutes LOCF(last observation carried forward)
|
65.3 mm Hg
Standard Deviation 13.30
|
59.9 mm Hg
Standard Deviation 15.43
|
53.5 mm Hg
Standard Deviation 12.09
|
59.6 mm Hg
Standard Deviation 17.82
|
59.5 mm Hg
Standard Deviation 15.28
|
PRIMARY outcome
Timeframe: 30 daysPopulation: ITT Safety Population consisted of all consented and randomized patients who received any amount of study medication
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment. Subjects will be followed for 30 days after discontinuation of study drug. The occurrence of Serious Adverse Events (SAEs) will be monitored for 30 days.
Outcome measures
| Measure |
0.3 mcg/kg/Min
n=50 Participants
Rate of SNP infusion during blinded study drug period
|
1 mcg/kg/Min
n=49 Participants
Rate of SNP infusion during blinded study drug period
|
2 mcg/kg/Min
n=53 Participants
Rate of SNP infusion during blinded study drug period
|
3 mcg/kg/Min
n=51 Participants
Rate of SNP infusion during blinded study drug period
|
Total
n=203 Participants
Total result
|
|---|---|---|---|---|---|
|
Overall Summary of Tolerability/Adverse Events (AEs) for ITT Safety Population
N of participants with MODERATE TEAE
|
19 participants
|
19 participants
|
20 participants
|
15 participants
|
73 participants
|
|
Overall Summary of Tolerability/Adverse Events (AEs) for ITT Safety Population
N of participants with at least one TEAE
|
50 participants
|
49 participants
|
53 participants
|
51 participants
|
203 participants
|
|
Overall Summary of Tolerability/Adverse Events (AEs) for ITT Safety Population
N of participants with at least one TESAE
|
5 participants
|
4 participants
|
5 participants
|
4 participants
|
18 participants
|
|
Overall Summary of Tolerability/Adverse Events (AEs) for ITT Safety Population
N with TEAE leading to study drug withdrawal
|
19 participants
|
18 participants
|
13 participants
|
16 participants
|
66 participants
|
|
Overall Summary of Tolerability/Adverse Events (AEs) for ITT Safety Population
N of participants with MILD TEAE
|
8 participants
|
10 participants
|
7 participants
|
8 participants
|
33 participants
|
|
Overall Summary of Tolerability/Adverse Events (AEs) for ITT Safety Population
N of participants with SEVERE TEAE
|
23 participants
|
20 participants
|
26 participants
|
28 participants
|
97 participants
|
|
Overall Summary of Tolerability/Adverse Events (AEs) for ITT Safety Population
N of participants with probably related TEAE
|
29 participants
|
32 participants
|
40 participants
|
36 participants
|
137 participants
|
|
Overall Summary of Tolerability/Adverse Events (AEs) for ITT Safety Population
N of participants with possibly related TEAE
|
12 participants
|
6 participants
|
2 participants
|
9 participants
|
29 participants
|
|
Overall Summary of Tolerability/Adverse Events (AEs) for ITT Safety Population
N of participants with Probably NOT related TEAE
|
1 participants
|
5 participants
|
0 participants
|
3 participants
|
9 participants
|
|
Overall Summary of Tolerability/Adverse Events (AEs) for ITT Safety Population
N of participants with NOT related TEAE
|
8 participants
|
6 participants
|
11 participants
|
3 participants
|
28 participants
|
|
Overall Summary of Tolerability/Adverse Events (AEs) for ITT Safety Population
N of Deaths
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 25 minutesPopulation: ITT Efficacy Evaluable Population consisted of randomized and treated patients who had a pre-treatment Baseline MAP and a second MAP determined within 25 minutes of study drug infusion at the starting dose.
Change From Baseline in MAP (mmHg) After 20 and 25 Minutes Double-Blind Infusion (Overall) for ITT Efficacy Evaluable Population.
Outcome measures
| Measure |
0.3 mcg/kg/Min
n=50 Participants
Rate of SNP infusion during blinded study drug period
|
1 mcg/kg/Min
n=49 Participants
Rate of SNP infusion during blinded study drug period
|
2 mcg/kg/Min
n=53 Participants
Rate of SNP infusion during blinded study drug period
|
3 mcg/kg/Min
n=51 Participants
Rate of SNP infusion during blinded study drug period
|
Total
n=203 Participants
Total result
|
|---|---|---|---|---|---|
|
Change From Baseline MAP Nitroprusside Infusion During the Blinded Infusion;
25 mins observed (n = 39,24,15,20,98)
|
69.5 mm Hg
Standard Deviation 12.15
|
64.4 mm Hg
Standard Deviation 10.30
|
60.5 mm Hg
Standard Deviation 10.53
|
66.4 mm Hg
Standard Deviation 13.07
|
66.2 mm Hg
Standard Deviation 11.94
|
|
Change From Baseline MAP Nitroprusside Infusion During the Blinded Infusion;
Change from BL - 25 mins (n = 39,24,15,20,98)
|
-6.9 mm Hg
Standard Deviation 11.80
|
-18.2 mm Hg
Standard Deviation 14.69
|
-10.2 mm Hg
Standard Deviation 13.82
|
-11.7 mm Hg
Standard Deviation 16.16
|
-11.1 mm Hg
Standard Deviation 14.21
|
|
Change From Baseline MAP Nitroprusside Infusion During the Blinded Infusion;
Baseline (BL) Observed (n = 50,49,53,51,203)
|
76.3 mm Hg
Standard Deviation 11.37
|
76.9 mm Hg
Standard Deviation 14.50
|
73.5 mm Hg
Standard Deviation 11.50
|
76.3 mm Hg
Standard Deviation 12.06
|
75.7 mm Hg
Standard Deviation 12.37
|
|
Change From Baseline MAP Nitroprusside Infusion During the Blinded Infusion;
20 Mins Observed (n = 42,27,19,26,114)
|
69.6 mm Hg
Standard Deviation 11.29
|
73.2 mm Hg
Standard Deviation 15.97
|
62.3 mm Hg
Standard Deviation 13.58
|
65.8 mm Hg
Standard Deviation 12.73
|
68.4 mm Hg
Standard Deviation 13.57
|
|
Change From Baseline MAP Nitroprusside Infusion During the Blinded Infusion;
Change from BL - 20 mins (n = 42,27,19,26,114)
|
-7.5 mm Hg
Standard Deviation 14.38
|
-10.0 mm Hg
Standard Deviation 16.37
|
-11.1 mm Hg
Standard Deviation 16.42
|
-12.5 mm Hg
Standard Deviation 14.09
|
-9.8 mm Hg
Standard Deviation 15.08
|
SECONDARY outcome
Timeframe: Up to the end of open label treatment (Approximately 120 minutes)Population: The Analysis population included the participants in the ITT Efficacy evaluable population who achieved target MAP. ITT Efficacy Evaluable Population consisted of randomized and treated patients who had a pre-treatment Baseline MAP and a second MAP determined within 30 minutes of study drug.
Infusion rate of sodium nitroprusside at which a predetermined clinically meaningful target value (+/- 10%) of MAP was achieved during study drug administration
Outcome measures
| Measure |
0.3 mcg/kg/Min
n=48 Participants
Rate of SNP infusion during blinded study drug period
|
1 mcg/kg/Min
n=49 Participants
Rate of SNP infusion during blinded study drug period
|
2 mcg/kg/Min
n=52 Participants
Rate of SNP infusion during blinded study drug period
|
3 mcg/kg/Min
n=51 Participants
Rate of SNP infusion during blinded study drug period
|
Total
n=200 Participants
Total result
|
|---|---|---|---|---|---|
|
Infusion Rate of Sodium Nitroprusside That Reduces MAP to a Predetermined Clinically Meaningful Target Value +/- 10%;
|
0.47 mcg/kg/min
Standard Deviation 0.519
|
0.70 mcg/kg/min
Standard Deviation 0.346
|
1.21 mcg/kg/min
Standard Deviation 0.678
|
1.86 mcg/kg/min
Standard Deviation 0.922
|
1.07 mcg/kg/min
Standard Deviation 0.843
|
SECONDARY outcome
Timeframe: To the end of open label treatment (approximately 120 minutes)Population: ITT Efficacy Evaluable Population consisted of randomized and treated patients who had a pre-treatment Baseline MAP and a second MAP determined within 30 minutes of study drug
Blinded Study Drug Administration Period: Started with study drug administration following stabilization of anesthesia. Patients were administered a blinded dose of SNP for up to 30 mins. This period ended at the start of open-label study drug infusion or at the completion of the blinded infusion if no open-label study drug was given. The follow-up period immediately followed for those patients not receiving open-label infusion. Blinded Treatment Phase II - gap between the end of blinded study drug infusion and the start of open-label study drug infusion Open-label treatment phase began with the start of open-label study drug infusion and was at least 90 mins in duration. SNP was initiated at a dose deemed appropriate by the investigator and was gradually adjusted to reach a target MAP based on clinical presentation and needs of the patient. Target MAP was not to be \< 50 mmHg (40 mmHg for patients \< 30 days of age). This period ended at the completion of open-label infusion.
Outcome measures
| Measure |
0.3 mcg/kg/Min
n=50 Participants
Rate of SNP infusion during blinded study drug period
|
1 mcg/kg/Min
n=49 Participants
Rate of SNP infusion during blinded study drug period
|
2 mcg/kg/Min
n=53 Participants
Rate of SNP infusion during blinded study drug period
|
3 mcg/kg/Min
n=51 Participants
Rate of SNP infusion during blinded study drug period
|
Total
n=203 Participants
Total result
|
|---|---|---|---|---|---|
|
Number of Participants Who Reach Target MAP;
Achieved target MAP
|
48 participants
|
49 participants
|
52 participants
|
51 participants
|
200 participants
|
|
Number of Participants Who Reach Target MAP;
Did NOT achieve target MAP
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants Who Reach Target MAP;
Not determined
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants Who Reach Target MAP;
Achieved during the blinded treatment
|
35 participants
|
36 participants
|
38 participants
|
39 participants
|
148 participants
|
|
Number of Participants Who Reach Target MAP;
Achieved during Blinded Phase II
|
0 participants
|
4 participants
|
8 participants
|
7 participants
|
19 participants
|
|
Number of Participants Who Reach Target MAP;
Achieved during Open-label Treatment
|
13 participants
|
9 participants
|
6 participants
|
5 participants
|
33 participants
|
Adverse Events
0.3 μg/kg/Min
Serious events: 24 serious events
Other events: 50 other events
Deaths: 0 deaths
1 μg/kg/Min
Serious events: 22 serious events
Other events: 49 other events
Deaths: 0 deaths
2 μg/kg/Min
Serious events: 18 serious events
Other events: 53 other events
Deaths: 0 deaths
3 μg/kg/Min
Serious events: 20 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.3 μg/kg/Min
n=50 participants at risk
Rate of SNP infusion during blinded study drug period
|
1 μg/kg/Min
n=49 participants at risk
Rate of SNP infusion during blinded study drug period
|
2 μg/kg/Min
n=53 participants at risk
Rate of SNP infusion during blinded study drug period
|
3 μg/kg/Min
n=51 participants at risk
Rate of study drug infusion during blinded study drug period
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
2.0%
1/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
3.8%
2/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
General disorders
Pseudocyst
|
0.00%
0/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
2.0%
1/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
General disorders
Pyrexia
|
0.00%
0/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
2.0%
1/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
2.0%
1/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Infections and infestations
Postoperative Infection
|
4.0%
2/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Infections and infestations
Sepsis
|
0.00%
0/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
2.0%
1/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Infections and infestations
Serratia Infection
|
2.0%
1/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Injury, poisoning and procedural complications
Cerebrospinal fluid Leakage
|
0.00%
0/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
1.9%
1/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Injury, poisoning and procedural complications
Infusion site extravasation
|
0.00%
0/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
2.0%
1/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Injury, poisoning and procedural complications
Operative Haemorrhage
|
0.00%
0/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
2.0%
1/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
2.0%
1/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
2.0%
1/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Investigations
Blood Pressure decreased
|
2.0%
1/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
4.1%
2/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
1.9%
1/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
2.0%
1/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Investigations
Cardiac output decreased
|
2.0%
1/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Investigations
Central Venous pressure increased
|
2.0%
1/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
2.0%
1/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
1.9%
1/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Nervous system disorders
Cauda Equina Syndrome
|
0.00%
0/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
2.0%
1/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
1.9%
1/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Renal and urinary disorders
Hypotonic Urinary Bladder
|
0.00%
0/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
2.0%
1/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
1.9%
1/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
1.9%
1/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
2.0%
1/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
2.0%
1/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Vascular disorders
Hypertension
|
0.00%
0/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
2.0%
1/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Vascular disorders
Rebound Hypertension
|
2.0%
1/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Vascular disorders
Hypotension
|
32.0%
16/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
30.6%
15/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
20.8%
11/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
29.4%
15/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Vascular disorders
Superior mesenteric artery syndrome
|
2.0%
1/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Investigations
Heart Rate increased
|
0.00%
0/50 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/49 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
1.9%
1/53 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
0.00%
0/51 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
Other adverse events
| Measure |
0.3 μg/kg/Min
n=50 participants at risk
Rate of SNP infusion during blinded study drug period
|
1 μg/kg/Min
n=49 participants at risk
Rate of SNP infusion during blinded study drug period
|
2 μg/kg/Min
n=53 participants at risk
Rate of SNP infusion during blinded study drug period
|
3 μg/kg/Min
n=51 participants at risk
Rate of study drug infusion during blinded study drug period
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
34.0%
17/50 • Number of events 17 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
26.5%
13/49 • Number of events 13 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
15.1%
8/53 • Number of events 8 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
21.6%
11/51 • Number of events 11 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Blood and lymphatic system disorders
Coagulopathy
|
6.0%
3/50 • Number of events 3 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
4.1%
2/49 • Number of events 2 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
7.5%
4/53 • Number of events 4 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
9.8%
5/51 • Number of events 5 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Cardiac disorders
Tachycardia
|
12.0%
6/50 • Number of events 6 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
22.4%
11/49 • Number of events 11 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
15.1%
8/53 • Number of events 8 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
11.8%
6/51 • Number of events 6 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Eye disorders
Eye Swelling
|
8.0%
4/50 • Number of events 4 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
8.2%
4/49 • Number of events 4 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
7.5%
4/53 • Number of events 4 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
7.8%
4/51 • Number of events 4 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Gastrointestinal disorders
Constipation
|
12.0%
6/50 • Number of events 6 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
14.3%
7/49 • Number of events 7 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
13.2%
7/53 • Number of events 7 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
11.8%
6/51 • Number of events 6 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Gastrointestinal disorders
Vomiting
|
28.0%
14/50 • Number of events 14 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
26.5%
13/49 • Number of events 13 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
39.6%
21/53 • Number of events 21 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
31.4%
16/51 • Number of events 16 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
General disorders
Face Oedema
|
12.0%
6/50 • Number of events 6 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
8.2%
4/49 • Number of events 4 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
15.1%
8/53 • Number of events 8 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
9.8%
5/51 • Number of events 5 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
General disorders
Pyrexia
|
32.0%
16/50 • Number of events 16 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
32.7%
16/49 • Number of events 16 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
28.3%
15/53 • Number of events 15 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
47.1%
24/51 • Number of events 24 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Investigations
Blood Pressure Increased
|
10.0%
5/50 • Number of events 5 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
8.2%
4/49 • Number of events 4 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
5.7%
3/53 • Number of events 3 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
2.0%
1/51 • Number of events 1 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Investigations
Oxygen saturation decreased
|
6.0%
3/50 • Number of events 3 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
6.1%
3/49 • Number of events 3 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
9.4%
5/53 • Number of events 5 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
11.8%
6/51 • Number of events 6 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Investigations
Urine Output decreased
|
16.0%
8/50 • Number of events 8 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
20.4%
10/49 • Number of events 10 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
17.0%
9/53 • Number of events 9 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
23.5%
12/51 • Number of events 12 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Metabolism and nutrition disorders
Acidosis
|
8.0%
4/50 • Number of events 4 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
6.1%
3/49 • Number of events 3 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
1.9%
1/53 • Number of events 1 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
9.8%
5/51 • Number of events 5 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.0%
6/50 • Number of events 6 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
8.2%
4/49 • Number of events 4 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
13.2%
7/53 • Number of events 7 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
5.9%
3/51 • Number of events 3 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.0%
1/50 • Number of events 1 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
10.2%
5/49 • Number of events 5 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
5.7%
3/53 • Number of events 3 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
5.9%
3/51 • Number of events 3 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
6.0%
3/50 • Number of events 3 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
8.2%
4/49 • Number of events 4 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
7.5%
4/53 • Number of events 4 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
3.9%
2/51 • Number of events 2 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
8.0%
4/50 • Number of events 4 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
8.2%
4/49 • Number of events 4 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
3.8%
2/53 • Number of events 2 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
2.0%
1/51 • Number of events 1 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Skin and subcutaneous tissue disorders
Periorbital Oedema
|
6.0%
3/50 • Number of events 3 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
10.2%
5/49 • Number of events 5 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
11.3%
6/53 • Number of events 6 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
9.8%
5/51 • Number of events 5 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Vascular disorders
Haemorrhage
|
12.0%
6/50 • Number of events 6 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
8.2%
4/49 • Number of events 4 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
13.2%
7/53 • Number of events 7 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
3.9%
2/51 • Number of events 2 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Vascular disorders
Hypertension
|
20.0%
10/50 • Number of events 10 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
22.4%
11/49 • Number of events 11 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
22.6%
12/53 • Number of events 12 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
37.3%
19/51 • Number of events 19 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Vascular disorders
Hypotension
|
70.0%
35/50 • Number of events 35 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
75.5%
37/49 • Number of events 37 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
75.5%
40/53 • Number of events 40 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
80.4%
41/51 • Number of events 41 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Vascular disorders
Rebound Hypertension
|
14.0%
7/50 • Number of events 7 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
20.4%
10/49 • Number of events 10 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
28.3%
15/53 • Number of events 15 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
31.4%
16/51 • Number of events 16 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
4.0%
2/50 • Number of events 2 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
8.2%
4/49 • Number of events 4 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
15.1%
8/53 • Number of events 8 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
7.8%
4/51 • Number of events 4 • Adverse events were monitored throughout the first 4 stages stages (prestudy drug administration, Blinded period, Open period,Follow-up period) of the study totalling upto 16 days.Serious adverse events was monitored for additional 30 days after follow-up
Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment.Serious Adverse events include AEs leading to study drug withdrawal
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place