Trial Outcomes & Findings for Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery (NCT NCT00507026)

Last Updated: 2021-10-29

Results Overview

Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 24 hours ranges from -2400 to 2400. A higher value indicates a better pain reduction.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

277 participants

Primary outcome timeframe

Over 24 hours post first dose

Results posted on

2021-10-29

Participant Flow

Participants who required elective general orthopedic surgery were eligible for participation in this study. Within 6 hours after completion of surgery, participants who experienced moderate to severe pain, as measured by a 0-100 millimeter (mm) visual analog scale (VAS) with pain intensity (PI) score of greater than or equal to (\>=) 50 mm and who met all eligibility criteria were enrolled into the study.

Total 432 participants signed the inform consent form (ICF). Out of which 155 participants were not admitted into the study, 277 actually enrolled into the study and assigned to study treatment.

Participant milestones

Participant milestones
Measure	Diclofenac (DIC075V) Participants at high risk (weighing less than \[\<\] 50 killogram \[k\]), age \>= 65 years, elevated nonsteroidal anti-inflammatory drugs \[NSAID\]-related gastrointestinal \[GI\] risk factors, or with hepatic or renal impairment) received DIC075V 18.75 milligram (mg). Participants without any risk factor and weighing greater than (\>) 95 kg received DIC075V 50 mg. Participants weighing \>95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as intravenous (IV) bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Ketorolac Participants at high risk (weighing \<50 k, \>=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing \>95 kg received ketorolac tromethamine 30 mg. Participants weighing \>95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Placebo Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
Overall Study STARTED	145	60	72
Overall Study COMPLETED	132	56	51
Overall Study NOT COMPLETED	13	4	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Diclofenac (DIC075V) Participants at high risk (weighing less than \[\<\] 50 killogram \[k\]), age \>= 65 years, elevated nonsteroidal anti-inflammatory drugs \[NSAID\]-related gastrointestinal \[GI\] risk factors, or with hepatic or renal impairment) received DIC075V 18.75 milligram (mg). Participants without any risk factor and weighing greater than (\>) 95 kg received DIC075V 50 mg. Participants weighing \>95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as intravenous (IV) bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Ketorolac Participants at high risk (weighing \<50 k, \>=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing \>95 kg received ketorolac tromethamine 30 mg. Participants weighing \>95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Placebo Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
Overall Study Lack of Efficacy	6	4	21
Overall Study Withdrawal by Subject	2	0	0
Overall Study Investigator Decision	1	0	0
Overall Study Adverse Event	2	0	0
Overall Study Protocol Violation	1	0	0
Overall Study Other	1	0	0

Baseline Characteristics

Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diclofenac (DIC075V) n=145 Participants Participants at high risk (weighing \<50 k), age \>= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing \>95 kg received DIC075V 50 mg. Participants weighing \>95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Ketorolac n=60 Participants Participants at high risk (weighing \<50 k, \>=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing \>95 kg received ketorolac tromethamine 30 mg. Participants weighing \>95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Placebo n=72 Participants Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Total n=277 Participants Total of all reporting groups
Age, Continuous	55.9 Years STANDARD_DEVIATION 14.35 • n=5 Participants	54.9 Years STANDARD_DEVIATION 15.77 • n=7 Participants	54.5 Years STANDARD_DEVIATION 15.67 • n=5 Participants	55.3 Years STANDARD_DEVIATION 14.97 • n=4 Participants
Sex: Female, Male Female	92 Participants n=5 Participants	40 Participants n=7 Participants	46 Participants n=5 Participants	178 Participants n=4 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	20 Participants n=7 Participants	26 Participants n=5 Participants	99 Participants n=4 Participants

PRIMARY outcome

Timeframe: Over 24 hours post first dose

Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Diclofenac (DIC075V) n=145 Participants Participants at high risk (weighing \<50 k), age \>= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing \>95 kg received DIC075V 50 mg. Participants weighing \>95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Ketorolac n=60 Participants Participants at high risk (weighing \<50 k, \>=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing \>95 kg received ketorolac tromethamine 30 mg. Participants weighing \>95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Placebo n=72 Participants Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
Sum of the Pain Intensity Differences (SPID) Over 24 Hours	577.0 mm*hours Standard Deviation 570.90	563.2 mm*hours Standard Deviation 586.21	28.0 mm*hours Standard Deviation 428.43

PRIMARY outcome

Timeframe: Over 48 hours post first dose

Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication.

Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 48 hours ranges from -4800 to 4800. A higher value indicates a better pain reduction.

Outcome measures

Outcome measures
Measure	Diclofenac (DIC075V) n=145 Participants Participants at high risk (weighing \<50 k), age \>= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing \>95 kg received DIC075V 50 mg. Participants weighing \>95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Ketorolac n=60 Participants Participants at high risk (weighing \<50 k, \>=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing \>95 kg received ketorolac tromethamine 30 mg. Participants weighing \>95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Placebo n=72 Participants Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
Sum of the Pain Intensity Differences (SPID) Over 48 Hours	1527.5 mm*hours Standard Deviation 1139.30	1371.8 mm*hours Standard Deviation 1152.19	400.4 mm*hours Standard Deviation 949.54

PRIMARY outcome

Timeframe: Over 72 hours post first dose

Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication.

Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 72 hours ranges from -7200 to 7200. A higher value indicates a better pain reduction.

Outcome measures

Outcome measures
Measure	Diclofenac (DIC075V) n=145 Participants Participants at high risk (weighing \<50 k), age \>= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing \>95 kg received DIC075V 50 mg. Participants weighing \>95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Ketorolac n=60 Participants Participants at high risk (weighing \<50 k, \>=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing \>95 kg received ketorolac tromethamine 30 mg. Participants weighing \>95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Placebo n=72 Participants Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
Sum of the Pain Intensity Differences (SPID) Over 72 Hours	2592.1 mm*hours Standard Deviation 1730.92	2312.1 mm*hours Standard Deviation 1743.73	836.8 mm*hours Standard Deviation 1564.24

PRIMARY outcome

Timeframe: Over 96 hours post first dose

Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication.

Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 96 hours ranges from -9600 to 9600. A higher value indicates a better pain reduction.

Outcome measures

Outcome measures
Measure	Diclofenac (DIC075V) n=145 Participants Participants at high risk (weighing \<50 k), age \>= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing \>95 kg received DIC075V 50 mg. Participants weighing \>95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Ketorolac n=60 Participants Participants at high risk (weighing \<50 k, \>=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing \>95 kg received ketorolac tromethamine 30 mg. Participants weighing \>95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Placebo n=72 Participants Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
Sum of the Pain Intensity Differences (SPID) Over 96 Hours	3711.3 mm*hours Standard Deviation 2347.25	3331.9 mm*hours Standard Deviation 2356.36	1337.8 mm*hours Standard Deviation 2261.50

PRIMARY outcome

Timeframe: Over 120 hours post first dose

Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication.

Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 120 hours ranges from -12000 to 12000. A higher value indicates a better pain reduction.

Outcome measures

Outcome measures
Measure	Diclofenac (DIC075V) n=145 Participants Participants at high risk (weighing \<50 k), age \>= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing \>95 kg received DIC075V 50 mg. Participants weighing \>95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Ketorolac n=60 Participants Participants at high risk (weighing \<50 k, \>=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing \>95 kg received ketorolac tromethamine 30 mg. Participants weighing \>95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Placebo n=72 Participants Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
Sum of the Pain Intensity Differences (SPID) Over 120 Hours	4835.6 mm*hours Standard Deviation 2988.78	4359.1 mm*hours Standard Deviation 3001.32	1840.5 mm*hours Standard Deviation 2987.85

SECONDARY outcome

Timeframe: Baseline (0 hour), 5, 10, 15, 30, 45 minutes post first dose, 1, 2, 3, 5, 6, 9, 12, 15, 18, 21, 24, 48, 72, 96, 120 hours post first dose

Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.

Outcome measures

Outcome measures
Measure	Diclofenac (DIC075V) n=144 Participants Participants at high risk (weighing \<50 k), age \>= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing \>95 kg received DIC075V 50 mg. Participants weighing \>95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Ketorolac n=60 Participants Participants at high risk (weighing \<50 k, \>=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing \>95 kg received ketorolac tromethamine 30 mg. Participants weighing \>95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Placebo n=71 Participants Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
Pain Intensity Differences (PID) Over Time At 2 hours	17.3 mm Standard Deviation 30.22	16.9 mm Standard Deviation 32.81	-7.8 mm Standard Deviation 23.86
Pain Intensity Differences (PID) Over Time At 3 hours	13.5 mm Standard Deviation 29.30	14.7 mm Standard Deviation 32.94	-8.9 mm Standard Deviation 19.21
Pain Intensity Differences (PID) Over Time At 96 hours	46.8 mm Standard Deviation 28.42	43.0 mm Standard Deviation 28.92	—
Pain Intensity Differences (PID) Over Time At 120 hours	46.9 mm Standard Deviation 28.42	42.9 mm Standard Deviation 28.91	20.9 mm Standard Deviation 31.48
Pain Intensity Differences (PID) Over Time At 5 hours	10.8 mm Standard Deviation 30.11	15.1 mm Standard Deviation 32.01	-7.3 mm Standard Deviation 20.76
Pain Intensity Differences (PID) Over Time At 6 hours	12.6 mm Standard Deviation 31.05	12.5 mm Standard Deviation 29.69	-6.1 mm Standard Deviation 21.31
Pain Intensity Differences (PID) Over Time At 9 hours	23.6 mm Standard Deviation 32.07	21.3 mm Standard Deviation 33.34	-1.8 mm Standard Deviation 22.91
Pain Intensity Differences (PID) Over Time At 12 hours	23.4 mm Standard Deviation 31.83	23.7 mm Standard Deviation 32.44	1.4 mm Standard Deviation 24.75
Pain Intensity Differences (PID) Over Time At 15 hours	28.5 mm Standard Deviation 31.34	23.2 mm Standard Deviation 35.19	1.1 mm Standard Deviation 25.35
Pain Intensity Differences (PID) Over Time At 18 hours	30.2 mm Standard Deviation 32.27	30.1 mm Standard Deviation 32.80	8.7 mm Standard Deviation 24.16
Pain Intensity Differences (PID) Over Time At 21 hours	36.3 mm Standard Deviation 31.03	39.1 mm Standard Deviation 32.41	8.8 mm Standard Deviation 26.66
Pain Intensity Differences (PID) Over Time At 24 hours	31.8 mm Standard Deviation 32.47	27.5 mm Standard Deviation 32.96	12.9 mm Standard Deviation 26.38
Pain Intensity Differences (PID) Over Time At 48 hours	42.9 mm Standard Deviation 29.17	35.5 mm Standard Deviation 30.38	19.4 mm Standard Deviation 29.69
Pain Intensity Differences (PID) Over Time At 72 hours	47.0 mm Standard Deviation 27.65	41.0 mm Standard Deviation 30.40	20.3 mm Standard Deviation 31.44
Pain Intensity Differences (PID) Over Time At 5 minutes	5.2 mm Standard Deviation 14.27	3.2 mm Standard Deviation 15.85	1.2 mm Standard Deviation 15.21
Pain Intensity Differences (PID) Over Time At 10 minutes	9.1 mm Standard Deviation 19.36	5.5 mm Standard Deviation 19.61	2.4 mm Standard Deviation 21.46
Pain Intensity Differences (PID) Over Time At 15 minutes	13.4 mm Standard Deviation 22.06	9.8 mm Standard Deviation 23.21	2.2 mm Standard Deviation 25.41
Pain Intensity Differences (PID) Over Time At 30 minutes	17.7 mm Standard Deviation 24.36	16.7 mm Standard Deviation 23.22	2.6 mm Standard Deviation 30.16
Pain Intensity Differences (PID) Over Time At 45 minutes	18.5 mm Standard Deviation 27.12	18.4 mm Standard Deviation 27.56	-1.2 mm Standard Deviation 30.15
Pain Intensity Differences (PID) Over Time At 1 hour	18.7 mm Standard Deviation 28.54	19.7 mm Standard Deviation 31.60	-4.2 mm Standard Deviation 28.03

SECONDARY outcome

Timeframe: Baseline (0 hour), 5, 30 minutes post first dose, 1, 24, 48, 72, 90, 120 hours post first dose

Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication.

Pain intensity was measured on a 0 to 100 mm VAS, larger values indicate greater pain intensity. In this outcome measure, percentage of participants attaining \>= 30 % reduction in pain intensity from baseline to specified time points was reported.

Outcome measures

Outcome measures
Measure	Diclofenac (DIC075V) n=145 Participants Participants at high risk (weighing \<50 k), age \>= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing \>95 kg received DIC075V 50 mg. Participants weighing \>95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Ketorolac n=60 Participants Participants at high risk (weighing \<50 k, \>=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing \>95 kg received ketorolac tromethamine 30 mg. Participants weighing \>95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Placebo n=72 Participants Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity At 5 minutes	13.8 Percentage of participants	10.0 Percentage of participants	8.3 Percentage of participants
Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity At 30 minutes	43.4 Percentage of participants	35.0 Percentage of participants	25.0 Percentage of participants
Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity At 1 hour	44.8 Percentage of participants	41.7 Percentage of participants	15.3 Percentage of participants
Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity At 24 hours	62.1 Percentage of participants	56.7 Percentage of participants	31.09 Percentage of participants
Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity At 48 hours	75.2 Percentage of participants	63.3 Percentage of participants	41.7 Percentage of participants
Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity At 72 hours	80.0 Percentage of participants	71.7 Percentage of participants	41.7 Percentage of participants
Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity At 90 hours	80.0 Percentage of participants	75.0 Percentage of participants	43.1 Percentage of participants
Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity At 120 hours	80.7 Percentage of participants	75.0 Percentage of participants	43.1 Percentage of participants

SECONDARY outcome

Timeframe: 0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose

Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication.

Pain relief values at specified time points were measured on a 0 to 100 mm VAS, where higher values indicate greater pain relief. TOTPAR over specified time interval was calculated as area under pain relief curve over specified time intervals using trapezoidal approximation. For 0-24 hours score range was 0-2400, for 0-48 hours score range was 0- 4800, for 0-96 hours score range was 0-9600 and for 0-120 hours score range was 0-12000. Higher TOTPAR values indicated more relief.

Outcome measures

Outcome measures
Measure	Diclofenac (DIC075V) n=145 Participants Participants at high risk (weighing \<50 k), age \>= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing \>95 kg received DIC075V 50 mg. Participants weighing \>95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Ketorolac n=60 Participants Participants at high risk (weighing \<50 k, \>=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing \>95 kg received ketorolac tromethamine 30 mg. Participants weighing \>95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Placebo n=72 Participants Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
Total Pain Relief (TOTPAR) 0-72 hours	4471.0 mm*hours Standard Deviation 1898.89	3983.6 mm*hours Standard Deviation 2056.63	2214.6 mm*hours Standard Deviation 2103.25
Total Pain Relief (TOTPAR) 0-96 hours	6252.2 mm*hours Standard Deviation 2577.46	5575.7 mm*hours Standard Deviation 2828.49	3159.4 mm*hours Standard Deviation 3002.62
Total Pain Relief (TOTPAR) 0-120 hours	8042.5 mm*hours Standard Deviation 3282.39	7178.0 mm*hours Standard Deviation 3627.97	4105.4 mm*hours Standard Deviation 3922.22
Total Pain Relief (TOTPAR) 0-24 hours	1177.6 mm*hours Standard Deviation 611.13	1065.4 mm*hours Standard Deviation 616.28	484.7 mm*hours Standard Deviation 502.91
Total Pain Relief (TOTPAR) 0-48 hours	2768.3 mm*hours Standard Deviation 1239.29	2453.8 mm*hours Standard Deviation 1323.35	1327.9 mm*hours Standard Deviation 1258.96

SECONDARY outcome

Timeframe: 5, 10, 15, 30, 45 minutes post first dose, 1, 2, 3, 5, 6, 9, 12, 15, 18, 21, 24, 48, 72, 96, 120 hours post first dose

Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication.

Pain relief values at specified time points were measured on a 0 to 100 mm VAS, where higher values indicate greater pain relief.

Outcome measures

Outcome measures
Measure	Diclofenac (DIC075V) n=145 Participants Participants at high risk (weighing \<50 k), age \>= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing \>95 kg received DIC075V 50 mg. Participants weighing \>95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Ketorolac n=60 Participants Participants at high risk (weighing \<50 k, \>=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing \>95 kg received ketorolac tromethamine 30 mg. Participants weighing \>95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Placebo n=72 Participants Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
Visual Analog Pain Relief Values Over the Time At 30 minutes	39.7 mm Standard Deviation 30.47	33.9 mm Standard Deviation 33.04	23.1 mm Standard Deviation 31.95
Visual Analog Pain Relief Values Over the Time At 45 minutes	41.6 mm Standard Deviation 33.14	33.3 mm Standard Deviation 33.64	19.9 mm Standard Deviation 31.67
Visual Analog Pain Relief Values Over the Time At 1 hour	40.0 mm Standard Deviation 34.64	37.8 mm Standard Deviation 37.21	17.1 mm Standard Deviation 30.67
Visual Analog Pain Relief Values Over the Time At 2 hours	35.3 mm Standard Deviation 36.99	33.2 mm Standard Deviation 37.98	10.1 mm Standard Deviation 23.97
Visual Analog Pain Relief Values Over the Time At 3 hours	33.5 mm Standard Deviation 37.06	29.5 mm Standard Deviation 37.09	8.0 mm Standard Deviation 22.07
Visual Analog Pain Relief Values Over the Time At 5 hours	28.8 mm Standard Deviation 35.45	31.0 mm Standard Deviation 36.74	8.0 mm Standard Deviation 21.96
Visual Analog Pain Relief Values Over the Time At 6 hours	36.7 mm Standard Deviation 34.78	33.9 mm Standard Deviation 32.54	12.6 mm Standard Deviation 24.10
Visual Analog Pain Relief Values Over the Time At 9 hours	49.5 mm Standard Deviation 35.12	39.4 mm Standard Deviation 34.59	17.5 mm Standard Deviation 26.20
Visual Analog Pain Relief Values Over the Time At 12 hours	51.6 mm Standard Deviation 33.42	46.3 mm Standard Deviation 34.44	21.6 mm Standard Deviation 27.46
Visual Analog Pain Relief Values Over the Time At 15 hours	55.7 mm Standard Deviation 33.55	45.9 mm Standard Deviation 34.08	21.4 mm Standard Deviation 26.15
Visual Analog Pain Relief Values Over the Time At 18 hours	56.6 mm Standard Deviation 33.00	53.6 mm Standard Deviation 33.98	28.3 mm Standard Deviation 30.07
Visual Analog Pain Relief Values Over the Time At 21 hours	63.6 mm Standard Deviation 32.75	63.2 mm Standard Deviation 33.05	27.4 mm Standard Deviation 32.73
Visual Analog Pain Relief Values Over the Time At 72 hours	74.4 mm Standard Deviation 31.01	64.8 mm Standard Deviation 35.41	38.8 mm Standard Deviation 38.77
Visual Analog Pain Relief Values Over the Time At 96 hours	74.6 mm Standard Deviation 31.11	67.0 mm Standard Deviation 34.96	39.4 mm Standard Deviation 39.19
Visual Analog Pain Relief Values Over the Time At 120 hours	74.6 mm Standard Deviation 31.15	66.9 mm Standard Deviation 34.89	39.4 mm Standard Deviation 39.19
Visual Analog Pain Relief Values Over the Time At 5 minutes	21.9 mm Standard Deviation 25.27	17.9 mm Standard Deviation 25.26	15.3 mm Standard Deviation 21.68
Visual Analog Pain Relief Values Over the Time At 10 minutes	27.1 mm Standard Deviation 26.89	23.6 mm Standard Deviation 28.15	19.0 mm Standard Deviation 24.27
Visual Analog Pain Relief Values Over the Time At 15 minutes	33.5 mm Standard Deviation 28.04	27.2 mm Standard Deviation 30.74	21.6 mm Standard Deviation 28.54
Visual Analog Pain Relief Values Over the Time At 24 hours	59.7 mm Standard Deviation 33.73	53.4 mm Standard Deviation 34.87	32.5 mm Standard Deviation 35.25
Visual Analog Pain Relief Values Over the Time At 48 hours	69.4 mm Standard Deviation 31.52	60.8 mm Standard Deviation 33.83	38.2 mm Standard Deviation 37.73

SECONDARY outcome

Timeframe: Maximum up to 5 days

Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. Missing data was imputed using worst observation carried forward (WOCF) recorded over prior six hours (including baseline, if appropriate) in this outcome measure.

Time from administration of study drug to administration of rescue medication were censored at time of last pain assessment for participants who did not receive rescue medication. Rescue medication was additional pain medication, available to participants if they did not receive pain relief from the study drug. Rescue medication available during this study was IV morphine.

Outcome measures

Outcome measures
Measure	Diclofenac (DIC075V) n=145 Participants Participants at high risk (weighing \<50 k), age \>= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing \>95 kg received DIC075V 50 mg. Participants weighing \>95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Ketorolac n=60 Participants Participants at high risk (weighing \<50 k, \>=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing \>95 kg received ketorolac tromethamine 30 mg. Participants weighing \>95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Placebo n=72 Participants Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
Time From Administration of Study Drug to Administration of Rescue Medication	220.0 Minutes Interval 125.0 to 272.0	137.0 Minutes Interval 63.0 to 302.0	51.0 Minutes Interval 35.0 to 71.0

SECONDARY outcome

Timeframe: 0-24, 0-48, 0-72, 0-96 and 0-120 hours

In this outcome measure, cumulative amount of rescue medication used over 0-24, 0-48, 0-72, 0-96, and 0-120 hours were reported. Rescue medication was additional pain medication, available to participants if they did not receive pain relief from the study drug. Rescue medication available during this study was IV morphine.

Outcome measures

Outcome measures
Measure	Diclofenac (DIC075V) n=107 Participants Participants at high risk (weighing \<50 k), age \>= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing \>95 kg received DIC075V 50 mg. Participants weighing \>95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Ketorolac n=44 Participants Participants at high risk (weighing \<50 k, \>=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing \>95 kg received ketorolac tromethamine 30 mg. Participants weighing \>95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Placebo n=68 Participants Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
Cumulative Amount of Rescue Medication 0-24 hours	9.4 mg Standard Deviation 7.20	11.5 mg Standard Deviation 7.81	16.0 mg Standard Deviation 10.61
Cumulative Amount of Rescue Medication 0-48 hours	11.1 mg Standard Deviation 9.06	15.5 mg Standard Deviation 13.99	19.0 mg Standard Deviation 13.89
Cumulative Amount of Rescue Medication 0-72 hours	11.7 mg Standard Deviation 9.56	18.0 mg Standard Deviation 20.11	20.5 mg Standard Deviation 16.19
Cumulative Amount of Rescue Medication 0-96 hours	11.8 mg Standard Deviation 9.73	18.1 mg Standard Deviation 20.14	20.5 mg Standard Deviation 16.17
Cumulative Amount of Rescue Medication 0-120 hours	11.8 mg Standard Deviation 9.73	18.1 mg Standard Deviation 20.17	20.5 mg Standard Deviation 16.17

SECONDARY outcome

Timeframe: 0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose

Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. Missing data was imputed using WOCF recorded over prior six hours (including baseline, if appropriate) in this outcome measure.

In this outcome measure, number of participants are reported according to number of times they received rescue medication. Rescue medication was additional pain medication, available to participants if they did not receive pain relief from the study drug. Rescue medication available during this study was IV morphine. Only those categories with at least one nonzero value are reported.

Outcome measures

Outcome measures
Measure	Diclofenac (DIC075V) n=145 Participants Participants at high risk (weighing \<50 k), age \>= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing \>95 kg received DIC075V 50 mg. Participants weighing \>95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Ketorolac n=60 Participants Participants at high risk (weighing \<50 k, \>=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing \>95 kg received ketorolac tromethamine 30 mg. Participants weighing \>95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Placebo n=72 Participants Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
Number of Participants According to Frequency of Use of Rescue Medication 0 - 24 Hours: 3	19 Participants	8 Participants	11 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0 - 24 Hours: 4	8 Participants	4 Participants	9 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0 - 24 Hours: 15	0 Participants	0 Participants	1 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-48 hours: 2	24 Participants	10 Participants	6 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-48 hours: 5	7 Participants	3 Participants	8 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-48 hours: 7	6 Participants	4 Participants	8 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-48 hours: 11	3 Participants	1 Participants	5 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-72 hours: 6	8 Participants	2 Participants	7 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-120 hours: 6	7 Participants	2 Participants	6 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-48 hours: 4	11 Participants	2 Participants	3 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0 - 24 Hours: 0	39 Participants	17 Participants	4 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0 - 24 Hours: 1	26 Participants	6 Participants	7 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0 - 24 Hours: 2	26 Participants	9 Participants	6 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0 - 24 Hours: 5	9 Participants	3 Participants	9 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0 - 24 Hours: 6	7 Participants	3 Participants	3 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0 - 24 Hours: 7	3 Participants	5 Participants	7 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0 - 24 Hours: 8	2 Participants	2 Participants	4 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0 - 24 Hours: 9	3 Participants	1 Participants	4 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0 - 24 Hours: 11	1 Participants	1 Participants	3 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0 - 24 Hours: 12	1 Participants	1 Participants	2 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0 - 24 Hours: 13	1 Participants	0 Participants	1 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0 - 24 Hours: 14	0 Participants	0 Participants	1 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-48 hours: 0	38 Participants	16 Participants	14 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-48 hours: 1	23 Participants	5 Participants	7 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-48 hours: 3	14 Participants	5 Participants	10 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-48 hours: 6	8 Participants	2 Participants	5 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-48 hours: 8	3 Participants	3 Participants	3 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-48 hours: 9	4 Participants	4 Participants	5 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-48 hours: 10	2 Participants	2 Participants	0 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-48 hours: 12	1 Participants	2 Participants	3 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-48 hours: 13	1 Participants	1 Participants	1 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-48 hours: 14	0 Participants	0 Participants	1 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-48 hours: 15	0 Participants	0 Participants	1 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-48 hours: 17	0 Participants	0 Participants	1 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-48 hours: 20	0 Participants	0 Participants	1 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-72 hours: 0	38 Participants	16 Participants	4 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-72 hours: 1	23 Participants	5 Participants	7 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-72 hours: 2	22 Participants	10 Participants	6 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-72 hours: 3	15 Participants	5 Participants	10 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-72 hours: 4	11 Participants	2 Participants	3 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-72 hours: 5	6 Participants	2 Participants	5 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-72 hours: 7	4 Participants	4 Participants	6 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-72 hours: 8	4 Participants	2 Participants	2 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-72 hours: 9	3 Participants	1 Participants	9 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-72 hours: 10	5 Participants	4 Participants	9 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-72 hours: 11	3 Participants	2 Participants	0 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-72 hours: 12	2 Participants	1 Participants	2 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-72 hours: 13	1 Participants	1 Participants	3 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-72 hours: 14	0 Participants	0 Participants	1 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-72 hours: 15	0 Participants	2 Participants	2 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-72 hours: 17	0 Participants	1 Participants	0 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-72 hours: 19	0 Participants	0 Participants	1 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-72 hours: 20	0 Participants	0 Participants	1 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-72 hours: 21	0 Participants	0 Participants	1 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-96 hours: 0	38 Participants	16 Participants	4 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-96 hours: 1	23 Participants	5 Participants	7 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-96 hours: 2	22 Participants	10 Participants	6 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-96 hours: 3	15 Participants	5 Participants	10 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-96 hours: 4	11 Participants	2 Participants	3 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-96 hours: 5	6 Participants	2 Participants	5 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-96 hours: 6	7 Participants	2 Participants	6 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-96 hours: 7	5 Participants	4 Participants	7 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-96 hours: 8	3 Participants	2 Participants	2 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-96 hours: 9	3 Participants	1 Participants	9 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-96 hours: 10	5 Participants	3 Participants	0 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-96 hours: 11	3 Participants	3 Participants	2 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-96 hours: 12	3 Participants	1 Participants	3 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-96 hours: 13	1 Participants	1 Participants	1 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-96 hours: 14	0 Participants	0 Participants	2 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-96 hours: 15	0 Participants	2 Participants	2 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-96 hours: 17	0 Participants	1 Participants	0 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-96 hours: 19	0 Participants	0 Participants	1 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-96 hours: 20	0 Participants	0 Participants	1 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-96 hours: 21	0 Participants	0 Participants	1 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-120 hours: 0	38 Participants	16 Participants	4 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-120 hours: 1	23 Participants	5 Participants	7 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-120 hours: 2	22 Participants	10 Participants	6 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-120 hours: 3	15 Participants	5 Participants	10 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-120 hours: 4	11 Participants	2 Participants	3 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-120 hours: 5	6 Participants	2 Participants	5 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-120 hours: 7	5 Participants	4 Participants	7 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-120 hours: 8	3 Participants	2 Participants	2 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-120 hours: 9	3 Participants	1 Participants	9 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-120 hours: 10	5 Participants	3 Participants	0 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-120 hours: 11	3 Participants	2 Participants	2 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-120 hours: 12	3 Participants	2 Participants	3 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-120 hours: 13	1 Participants	1 Participants	1 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-120 hours: 14	0 Participants	0 Participants	2 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-120 hours: 15	0 Participants	2 Participants	2 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-120 hours: 17	0 Participants	1 Participants	0 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-120 hours: 19	0 Participants	0 Participants	1 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-120 hours: 20	0 Participants	0 Participants	1 Participants
Number of Participants According to Frequency of Use of Rescue Medication 0-120 hours: 21	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 0-24, 0-48, 0-120 hours post-dose

Participants global evaluation of study medication was accessed on a scale ranging from scale 0 to 4 where 0= poor, 1= fair, 2= good, 3= very good, 4= excellent where higher score represented better outcome.

Outcome measures

Outcome measures
Measure	Diclofenac (DIC075V) n=141 Participants Participants at high risk (weighing \<50 k), age \>= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing \>95 kg received DIC075V 50 mg. Participants weighing \>95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Ketorolac n=59 Participants Participants at high risk (weighing \<50 k, \>=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing \>95 kg received ketorolac tromethamine 30 mg. Participants weighing \>95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Placebo n=70 Participants Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
Participant Global Evaluation Over Time 0-24 Hours	2.6 Units on a scale Standard Deviation 1.27	2.4 Units on a scale Standard Deviation 1.16	1.1 Units on a scale Standard Deviation 1.25
Participant Global Evaluation Over Time 0-48 Hours	2.9 Units on a scale Standard Deviation 1.15	2.6 Units on a scale Standard Deviation 0.86	1.9 Units on a scale Standard Deviation 1.42
Participant Global Evaluation Over Time 0-120 Hours	2.9 Units on a scale Standard Deviation 1.26	2.6 Units on a scale Standard Deviation 1.16	1.3 Units on a scale Standard Deviation 1.38

SECONDARY outcome

Timeframe: Within 6 hours of first dose on Day 1

Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication.

Participants were instructed to stop the first stopwatch at the onset of perceptible pain relief after first dose. Event times of participants not reporting perceptible relief were censored at 6 hours; event times of participants who withdrew or were administered rescue medication were censored at time of withdrawal or rescue. Kaplan-Meier estimate was used for analysis.

Outcome measures

Outcome measures
Measure	Diclofenac (DIC075V) n=145 Participants Participants at high risk (weighing \<50 k), age \>= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing \>95 kg received DIC075V 50 mg. Participants weighing \>95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Ketorolac n=60 Participants Participants at high risk (weighing \<50 k, \>=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing \>95 kg received ketorolac tromethamine 30 mg. Participants weighing \>95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Placebo n=72 Participants Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
Time to Perceptible Relief	10.0 Minutes Interval 0.0 to 194.0	14.4 Minutes Interval 0.0 to 85.0	15.0 Minutes Interval 1.0 to 187.0

SECONDARY outcome

Timeframe: Within 6 hours of first dose on Day 1

Population: ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication.

Participants were instructed to stop the second stopwatch at the onset of meaningful pain relief after first dose. Event times of participants not reporting meaningful relief were censored at 6 hours; event times of participants who withdrew or were administered rescue medication were censored at time of withdrawal or rescue. Kaplan-Meier estimate was used for analysis.

Outcome measures

Outcome measures
Measure	Diclofenac (DIC075V) n=145 Participants Participants at high risk (weighing \<50 k), age \>= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing \>95 kg received DIC075V 50 mg. Participants weighing \>95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Ketorolac n=60 Participants Participants at high risk (weighing \<50 k, \>=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing \>95 kg received ketorolac tromethamine 30 mg. Participants weighing \>95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Placebo n=72 Participants Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
Time to Meaningful Relief	41.6 Minutes Interval 31.0 to 58.6	42.5 Minutes Interval 30.0 to 51.7	NA Minutes Median and 95 % CI were not estimable as majority of participants in placebo arm did not achieve meaningful relief by 6 hours.

Adverse Events

Diclofenac (DIC075V)

Serious events: 7 serious events

Other events: 109 other events

Deaths: 0 deaths

Ketorolac

Serious events: 4 serious events

Other events: 46 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 60 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Diclofenac (DIC075V) n=145 participants at risk Participants at high risk (weighing \<50 k), age \>= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing \>95 kg received DIC075V 50 mg. Participants weighing \>95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Ketorolac n=60 participants at risk Participants at high risk (weighing \<50 k, \>=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing \>95 kg received ketorolac tromethamine 30 mg. Participants weighing \>95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.	Placebo n=72 participants at risk Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration.
Cardiac disorders Cardiac failure congestive	0.00% 0/145 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.7% 1/60 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/72 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Eye disorders Blindness unilateral	0.00% 0/145 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/60 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.4% 1/72 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Abdominal pain	0.69% 1/145 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/60 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/72 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Clostridium difficile colitis	0.69% 1/145 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/60 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/72 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Staphylococcal infection	0.00% 0/145 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.7% 1/60 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/72 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Urinary tract infection	0.00% 0/145 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.7% 1/60 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/72 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/145 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.7% 1/60 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/72 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Injury, poisoning and procedural complications Seroma	0.69% 1/145 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/60 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/72 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.69% 1/145 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/60 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/72 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Renal and urinary disorders Renal failure acute	0.69% 1/145 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/60 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/72 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/145 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/60 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.4% 1/72 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Deep vein thrombosis	2.1% 3/145 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/60 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/72 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Hypotension	0.00% 0/145 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/60 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	1.4% 1/72 Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

Other adverse events

Additional Information

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Results disclosure agreements

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Restriction type: OTHER