Trial Outcomes & Findings for Effect of Tafoxiparin on Cervical Ripening and Induction of Labor in Term Pregnant Women With an Unripe Cervix (NCT NCT04000438)
NCT ID: NCT04000438
Last Updated: 2025-05-06
Results Overview
Cervical ripening rate during up to the first seven days of treatment, measured by Bishop Score - Slope. Bishop score is an Assessment of the cervical stage by its: dilatation, position, effacement and consistency. The score was calculated as the sum of the following 5 categories where each category is scored between 0-2: * Fetal station (0-2) * Cervical diameter at inner meatus (0-2) * Cervical effacement (0-2) * Consistency at inner meatus (0-2) * Cervical position (0-2) Graded from 0-10, Bishop score of ≤ 4 is unripe and ≥ 6 is ripe. Bishop score was measured daily from start of treatment up until 7 days. The cervical ripening rate was calculated from the slope of the curve (score/day) when plotting Bishop score against days of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
365 participants
Primary outcome timeframe
Daily measures of Bishop Score from start of study drug administration until delivery (up to 7 days).
Results posted on
2025-05-06
Participant Flow
Number of subjects screened/enrolled: 365 Number of subjects started: 348 Reason: 17 subjects did not pass inclusion/exclusion
Participant milestones
| Measure |
Experimental DF01 High Dose
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins
|
Experimental: DF01 Medium Dose
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins
|
Experimental: DF01 Low Dose
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins
|
Placebo Comparator: PL1
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
PL1: The subject receives sc injections of placebo solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
91
|
85
|
83
|
89
|
|
Overall Study
COMPLETED
|
90
|
85
|
82
|
86
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental DF01 High Dose
n=91 Participants
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins.
|
Experimental: DF01 Medium Dose
n=85 Participants
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins.
|
Experimental: DF01 Low Dose
n=83 Participants
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins.
|
Placebo Comparator: PL1
n=89 Participants
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
PL1: The subject receives sc injections of placebo solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins
|
Total
n=348 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=91 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=83 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=348 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
91 Participants
n=91 Participants
|
85 Participants
n=85 Participants
|
83 Participants
n=83 Participants
|
89 Participants
n=89 Participants
|
348 Participants
n=348 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=91 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=83 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=348 Participants
|
|
Age, Continuous
|
31.2 years
STANDARD_DEVIATION 4.34 • n=91 Participants
|
31.4 years
STANDARD_DEVIATION 4.22 • n=85 Participants
|
31.6 years
STANDARD_DEVIATION 5.28 • n=83 Participants
|
31.3 years
STANDARD_DEVIATION 5.04 • n=89 Participants
|
31.4 years
STANDARD_DEVIATION 4.73 • n=348 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=91 Participants
|
85 Participants
n=85 Participants
|
83 Participants
n=83 Participants
|
89 Participants
n=89 Participants
|
348 Participants
n=348 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=91 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=83 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=348 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Sweden
|
27 participants
n=91 Participants
|
30 participants
n=85 Participants
|
26 participants
n=83 Participants
|
28 participants
n=89 Participants
|
111 participants
n=348 Participants
|
|
Region of Enrollment
Finland
|
64 participants
n=91 Participants
|
55 participants
n=85 Participants
|
57 participants
n=83 Participants
|
61 participants
n=89 Participants
|
237 participants
n=348 Participants
|
PRIMARY outcome
Timeframe: Daily measures of Bishop Score from start of study drug administration until delivery (up to 7 days).Cervical ripening rate during up to the first seven days of treatment, measured by Bishop Score - Slope. Bishop score is an Assessment of the cervical stage by its: dilatation, position, effacement and consistency. The score was calculated as the sum of the following 5 categories where each category is scored between 0-2: * Fetal station (0-2) * Cervical diameter at inner meatus (0-2) * Cervical effacement (0-2) * Consistency at inner meatus (0-2) * Cervical position (0-2) Graded from 0-10, Bishop score of ≤ 4 is unripe and ≥ 6 is ripe. Bishop score was measured daily from start of treatment up until 7 days. The cervical ripening rate was calculated from the slope of the curve (score/day) when plotting Bishop score against days of treatment.
Outcome measures
| Measure |
Experimental DF01 High Dose
n=91 Participants
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
DF01: TThe subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins.
|
Experimental: DF01 Medium Dose
n=85 Participants
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins.
|
Experimental: DF01 Low Dose
n=83 Participants
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins.
|
Placebo Comparator: PL1
n=88 Participants
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
PL1: The subject receives sc injections of placebo solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins.
|
|---|---|---|---|---|
|
Cervical Ripening Rate, Measured by Bishop Score - Slope
|
0.86 Slope (Bishop Score/day)
Standard Deviation 0.062
|
0.81 Slope (Bishop Score/day)
Standard Deviation 0.062
|
0.78 Slope (Bishop Score/day)
Standard Deviation 0.061
|
0.62 Slope (Bishop Score/day)
Standard Deviation 0.060
|
Adverse Events
Experimental DF01 High Dose
Serious events: 6 serious events
Other events: 52 other events
Deaths: 0 deaths
Experimental: DF01 Medium Dose
Serious events: 7 serious events
Other events: 54 other events
Deaths: 0 deaths
Experimental: DF01 Low Dose
Serious events: 2 serious events
Other events: 54 other events
Deaths: 0 deaths
Placebo Comparator: PL1
Serious events: 2 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental DF01 High Dose
n=91 participants at risk
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins.
|
Experimental: DF01 Medium Dose
n=85 participants at risk
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins.
|
Experimental: DF01 Low Dose
n=83 participants at risk
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins.
|
Placebo Comparator: PL1
n=88 participants at risk
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
DF01: The subject receives sc injections of placebo solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins
|
|---|---|---|---|---|
|
Infections and infestations
Amniotic cavity infection
|
2.2%
2/91 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Infections and infestations
Sepsis
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Infections and infestations
Postpartum sepsis
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
2.2%
2/91 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Bradycardia foetal
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Investigations
Total bile acids increased
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Nervous system disorders
Procedural headache
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Vascular disorders
Hypertension
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
Other adverse events
| Measure |
Experimental DF01 High Dose
n=91 participants at risk
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins.
|
Experimental: DF01 Medium Dose
n=85 participants at risk
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins.
|
Experimental: DF01 Low Dose
n=83 participants at risk
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins.
|
Placebo Comparator: PL1
n=88 participants at risk
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
DF01: The subject receives sc injections of placebo solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins
|
|---|---|---|---|---|
|
General disorders
Chills
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
General disorders
Injection site erythema
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
2.4%
2/85 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
General disorders
Pain
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
General disorders
Injection site pruritus
|
1.1%
1/91 • Number of events 5 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
General disorders
Feeling hot
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
General disorders
Malaise
|
2.2%
2/91 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
General disorders
Injection site warmth
|
2.2%
2/91 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
General disorders
Hyperhidrosis
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
General disorders
Chest discomfort
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
General disorders
Asthenia
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
General disorders
Puncture site haemorrhage
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
General disorders
Injection site reaction
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Gastrointestinal disorders
Nausea
|
2.2%
2/91 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
7.1%
6/85 • Number of events 7 • From first dose to until discharge from hospital, an average of 9.3 days.
|
2.4%
2/83 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
6.8%
6/88 • Number of events 6 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Perineal injury
|
2.2%
2/91 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
20.0%
17/85 • Number of events 17 • From first dose to until discharge from hospital, an average of 9.3 days.
|
25.3%
21/83 • Number of events 21 • From first dose to until discharge from hospital, an average of 9.3 days.
|
4.5%
4/88 • Number of events 4 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Bradycardia foetal
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
7.1%
6/85 • Number of events 6 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Tachycardia foetal
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
3.5%
3/85 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
3.6%
3/83 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
2.4%
2/85 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
3.6%
3/83 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
3.4%
3/88 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Uterine atony
|
3.3%
3/91 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Retained placenta or membranes
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
3.6%
3/83 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Oligohydramnios
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
2.4%
2/83 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal distress syndrome
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
3.4%
3/88 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Labour pain
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
2.4%
2/85 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Inferior vena cava syndrome
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Symphysiolysis
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal hypokinesia
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Transient tachypnoea of the newborn
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged labour
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Placental calcification
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Pelvic haematoma obstetric
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Uterine hyperstimulation
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Pregnancy, puerperium and perinatal conditions
Uterine contractions abnormal
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
General disorders
Pyrexia
|
8.8%
8/91 • Number of events 8 • From first dose to until discharge from hospital, an average of 9.3 days.
|
10.6%
9/85 • Number of events 9 • From first dose to until discharge from hospital, an average of 9.3 days.
|
13.3%
11/83 • Number of events 11 • From first dose to until discharge from hospital, an average of 9.3 days.
|
8.0%
7/88 • Number of events 7 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
General disorders
Injection site pain
|
8.8%
8/91 • Number of events 14 • From first dose to until discharge from hospital, an average of 9.3 days.
|
2.4%
2/85 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
General disorders
Fatigue
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
4.7%
4/85 • Number of events 4 • From first dose to until discharge from hospital, an average of 9.3 days.
|
6.0%
5/83 • Number of events 6 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
General disorders
Injection site bruising
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
3.5%
3/85 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
General disorders
Injection site discolouration
|
3.3%
3/91 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
General disorders
Peripheral swelling
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
2.4%
2/85 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
General disorders
Injection site swelling
|
2.2%
2/91 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
2.4%
2/85 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
2/91 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
7.1%
6/85 • Number of events 6 • From first dose to until discharge from hospital, an average of 9.3 days.
|
6.0%
5/83 • Number of events 5 • From first dose to until discharge from hospital, an average of 9.3 days.
|
3.4%
3/88 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.2%
2/91 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
3.6%
3/83 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
4.5%
4/88 • Number of events 4 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
3.6%
3/83 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Nervous system disorders
Headache
|
6.6%
6/91 • Number of events 6 • From first dose to until discharge from hospital, an average of 9.3 days.
|
8.2%
7/85 • Number of events 7 • From first dose to until discharge from hospital, an average of 9.3 days.
|
9.6%
8/83 • Number of events 10 • From first dose to until discharge from hospital, an average of 9.3 days.
|
5.7%
5/88 • Number of events 5 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Nervous system disorders
Dizziness
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
2.4%
2/83 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
3.4%
3/88 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Nervous system disorders
Insomnia
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
2.4%
2/83 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Nervous system disorders
Tremor
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Nervous system disorders
Post lumbar puncture syndrome
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Nervous system disorders
Aura
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Renal and urinary disorders
Urinary retention
|
6.6%
6/91 • Number of events 6 • From first dose to until discharge from hospital, an average of 9.3 days.
|
11.8%
10/85 • Number of events 10 • From first dose to until discharge from hospital, an average of 9.3 days.
|
7.2%
6/83 • Number of events 6 • From first dose to until discharge from hospital, an average of 9.3 days.
|
8.0%
7/88 • Number of events 8 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Renal and urinary disorders
Dysuria
|
2.2%
2/91 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Renal and urinary disorders
Proteinuria
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Renal and urinary disorders
Glycosuria
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Renal and urinary disorders
Leukocyturia
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Investigations
Haemoglobin decreased
|
6.6%
6/91 • Number of events 6 • From first dose to until discharge from hospital, an average of 9.3 days.
|
2.4%
2/85 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
4.8%
4/83 • Number of events 4 • From first dose to until discharge from hospital, an average of 9.3 days.
|
3.4%
3/88 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Investigations
Hepatic enzyme increased
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
2.4%
2/85 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Investigations
Foetal monitoring abnormal
|
2.2%
2/91 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
2.3%
2/88 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Investigations
Blood lactate dehydrogenase abnormal
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Investigations
Protein urine present
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Investigations
Cardiac murmur
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Investigations
Visual analogue scale
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Reproductive system and breast disorders
Vulvovaginal injury
|
2.2%
2/91 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
5.7%
5/88 • Number of events 5 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Reproductive system and breast disorders
Cervical discharge
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
2.4%
2/85 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
2.4%
2/83 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Reproductive system and breast disorders
Endometriosis
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Reproductive system and breast disorders
Vaginal haematoma
|
2.2%
2/91 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Infections and infestations
Amniotic cavity infection
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Infections and infestations
COVID-19
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
2.4%
2/83 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
2.4%
2/83 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Infections and infestations
Infection
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Infections and infestations
Rhinitis
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Infections and infestations
Genital herpes simplex
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
7.1%
6/85 • Number of events 6 • From first dose to until discharge from hospital, an average of 9.3 days.
|
3.6%
3/83 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.1%
1/91 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Blood and lymphatic system disorders
Thymus enlargement
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Vascular disorders
Hypertension
|
3.3%
3/91 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Vascular disorders
Haemorrhage
|
2.2%
2/91 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
3.4%
3/88 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Vascular disorders
Epistaxis
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Vascular disorders
Haematoma
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Vascular disorders
Vulval haematoma
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
4.7%
4/85 • Number of events 4 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Surgical and medical procedures
Bladder catheterisation
|
6.6%
6/91 • Number of events 6 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
3.4%
3/88 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Surgical and medical procedures
Caesarean section
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Surgical and medical procedures
Episiotomy
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Surgical and medical procedures
Epidural anaesthesia
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
2.3%
2/88 • Number of events 3 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
2.2%
2/91 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Injury, poisoning and procedural complications
Anal sphincter injury
|
2.2%
2/91 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
2.3%
2/88 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
2.4%
2/85 • Number of events 2 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Injury, poisoning and procedural complications
Obstetric procedure complication
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
1.1%
1/91 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/83 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Eye disorders
Visual impairment
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/85 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.1%
1/88 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/91 • From first dose to until discharge from hospital, an average of 9.3 days.
|
1.2%
1/85 • Number of events 1 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/83 • From first dose to until discharge from hospital, an average of 9.3 days.
|
0.00%
0/88 • From first dose to until discharge from hospital, an average of 9.3 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place