Trial Outcomes & Findings for Capsaicin + Diclofenac Gel in Acute Back Pain or Neck Pain (NCT NCT02700815)

Last Updated: 2019-05-06

Results Overview

Pain on movement (POM) was used to assess pain measurement for back and neck pain. The standardized movements have been established for which the measurement was taken. POMwp was the POM measure that gave the highest score at baseline; i.e. POM of worst procedure. Pain intensity was assessed at rest after standing in an upright position relatively motionless for 1 minute. The pain was evaluated by asking patient 'How would you rate your pain right now?' and by using a visual analogue scale (VAS) ranging from 0-10 centimeters (cm) wherein 0 cm = no pain to 10 cm = worst pain possible. The results presented here are adjusted mean change from baseline and standard error for POMwp in cm.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

746 participants

Primary outcome timeframe

Baseline and Day 2

Results posted on

2019-05-06

Participant Flow

This was a randomised, placebo and active treatment-controlled, double-blind, parallel group study. Out of 757 enrolled patients with acute back or neck pain, 746 were randomised and treated with 4 topical treatments administered twice daily for 4 to 7 days.

All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be entered to trial if any of the specific entry criteria were not met.

Participant milestones

Participant milestones
Measure	Placebo Gel Patients were topically applied matching Placebo 2 gram (g) gel, twice daily with 12 ± 4 hours (h) between applications.	Capsaicin (0.075%) Gel Patients were topically applied Capsaicin 2 g gel (1.5 milligram (mg) Capsaicin), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) Gel Patients were topically applied Diclofenac 2 g gel (40 milligram (mg) Diclofenac), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) +Capsaicin (0.075%) Gel Patients were topically applied Diclofenac + Capsaicin 2 g gel (40 mg diclofenac, 1.5 mg capsaicin), twice daily with 12 ± 4 hours (h) between applications.
Overall Study STARTED	75	223	223	225
Overall Study COMPLETED	74	216	219	218
Overall Study NOT COMPLETED	1	7	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Gel Patients were topically applied matching Placebo 2 gram (g) gel, twice daily with 12 ± 4 hours (h) between applications.	Capsaicin (0.075%) Gel Patients were topically applied Capsaicin 2 g gel (1.5 milligram (mg) Capsaicin), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) Gel Patients were topically applied Diclofenac 2 g gel (40 milligram (mg) Diclofenac), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) +Capsaicin (0.075%) Gel Patients were topically applied Diclofenac + Capsaicin 2 g gel (40 mg diclofenac, 1.5 mg capsaicin), twice daily with 12 ± 4 hours (h) between applications.
Overall Study Adverse Event	0	6	2	3
Overall Study Lack of Efficacy	0	0	1	2
Overall Study Lost to Follow-up	1	0	0	1
Overall Study Refusal to continue medication	0	1	0	1
Overall Study Withdrawal by Subject	0	0	1	0

Baseline Characteristics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Gel n=75 Participants Patients were topically applied matching Placebo 2 gram (g) gel, twice daily with 12 ± 4 hours (h) between applications.	Capsaicin (0.075%) Gel n=223 Participants Patients were topically applied Capsaicin 2 g gel (1.5 milligram (mg) Capsaicin), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) Gel n=223 Participants Patients were topically applied Diclofenac 2 g gel (40 milligram (mg) Diclofenac), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) +Capsaicin (0.075%) Gel n=225 Participants Patients were topically applied Diclofenac + Capsaicin 2 g gel (40 mg diclofenac, 1.5 mg capsaicin), twice daily with 12 ± 4 hours (h) between applications.	Total n=746 Participants Total of all reporting groups
Age, Continuous	45.3 Years STANDARD_DEVIATION 14.78 • n=5 Participants • TS	43.2 Years STANDARD_DEVIATION 15.42 • n=7 Participants • TS	44.0 Years STANDARD_DEVIATION 15.96 • n=5 Participants • TS	44.2 Years STANDARD_DEVIATION 15.49 • n=4 Participants • TS	43.9 Years STANDARD_DEVIATION 15.52 • n=21 Participants • TS
Sex: Female, Male Female	44 Participants n=5 Participants • TS	128 Participants n=7 Participants • TS	136 Participants n=5 Participants • TS	136 Participants n=4 Participants • TS	444 Participants n=21 Participants • TS
Sex: Female, Male Male	31 Participants n=5 Participants • TS	95 Participants n=7 Participants • TS	87 Participants n=5 Participants • TS	89 Participants n=4 Participants • TS	302 Participants n=21 Participants • TS
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants • TS	3 Participants n=7 Participants • TS	3 Participants n=5 Participants • TS	3 Participants n=4 Participants • TS	9 Participants n=21 Participants • TS
Ethnicity (NIH/OMB) Not Hispanic or Latino	75 Participants n=5 Participants • TS	220 Participants n=7 Participants • TS	220 Participants n=5 Participants • TS	222 Participants n=4 Participants • TS	737 Participants n=21 Participants • TS
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • TS	0 Participants n=7 Participants • TS	0 Participants n=5 Participants • TS	0 Participants n=4 Participants • TS	0 Participants n=21 Participants • TS
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • TS	1 Participants n=7 Participants • TS	0 Participants n=5 Participants • TS	1 Participants n=4 Participants • TS	2 Participants n=21 Participants • TS
Race (NIH/OMB) Asian	2 Participants n=5 Participants • TS	3 Participants n=7 Participants • TS	0 Participants n=5 Participants • TS	2 Participants n=4 Participants • TS	7 Participants n=21 Participants • TS
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • TS	0 Participants n=7 Participants • TS	0 Participants n=5 Participants • TS	0 Participants n=4 Participants • TS	0 Participants n=21 Participants • TS
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants • TS	1 Participants n=7 Participants • TS	1 Participants n=5 Participants • TS	3 Participants n=4 Participants • TS	5 Participants n=21 Participants • TS
Race (NIH/OMB) White	73 Participants n=5 Participants • TS	216 Participants n=7 Participants • TS	218 Participants n=5 Participants • TS	216 Participants n=4 Participants • TS	723 Participants n=21 Participants • TS
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • TS	2 Participants n=7 Participants • TS	4 Participants n=5 Participants • TS	3 Participants n=4 Participants • TS	9 Participants n=21 Participants • TS
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • TS	0 Participants n=7 Participants • TS	0 Participants n=5 Participants • TS	0 Participants n=4 Participants • TS	0 Participants n=21 Participants • TS
Pain on movement of worst procedure (POMwp)	7.20 Units on scale STANDARD_DEVIATION 1.246 • n=5 Participants • TS	7.22 Units on scale STANDARD_DEVIATION 1.157 • n=7 Participants • TS	7.29 Units on scale STANDARD_DEVIATION 1.274 • n=5 Participants • TS	7.28 Units on scale STANDARD_DEVIATION 1.148 • n=4 Participants • TS	7.26 Units on scale STANDARD_DEVIATION 1.198 • n=21 Participants • TS
Country Germany	69 Participants n=5 Participants • TS	205 Participants n=7 Participants • TS	205 Participants n=5 Participants • TS	205 Participants n=4 Participants • TS	684 Participants n=21 Participants • TS
Country Russia	6 Participants n=5 Participants • TS	18 Participants n=7 Participants • TS	18 Participants n=5 Participants • TS	20 Participants n=4 Participants • TS	62 Participants n=21 Participants • TS
Application site Neck	45 Participants n=5 Participants • TS	126 Participants n=7 Participants • TS	129 Participants n=5 Participants • TS	130 Participants n=4 Participants • TS	430 Participants n=21 Participants • TS
Application site Back	30 Participants n=5 Participants • TS	97 Participants n=7 Participants • TS	94 Participants n=5 Participants • TS	95 Participants n=4 Participants • TS	316 Participants n=21 Participants • TS

PRIMARY outcome

Timeframe: Baseline and Day 2

Population: Full analysis set (FAS): All patients in treated set with a baseline value pre application for POMwp at Visit 1 and at least 1 POMwp value during assessment times at Visit 1 (Day 1 morning 1h after application), Visit 2 (Day 2, morning 1h after application), Visit 3 (Day 2 evening before application) or Visit 3 (Day 2 evening 1h after application)

Outcome measures

Outcome measures
Measure	Placebo Gel n=75 Participants Patients were topically applied matching Placebo 2 gram (g) gel, twice daily with 12 ± 4 hours (h) between applications.	Capsaicin (0.075%) Gel n=222 Participants Patients were topically applied Capsaicin 2 g gel (1.5 milligram (mg) Capsaicin), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) Gel n=222 Participants Patients were topically applied Diclofenac 2 g gel (40 milligram (mg) Diclofenac), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) +Capsaicin (0.075%) Gel n=225 Participants Patients were topically applied Diclofenac + Capsaicin 2 g gel (40 mg diclofenac, 1.5 mg capsaicin), twice daily with 12 ± 4 hours (h) between applications.
Change in POM Between Baseline and Day 2 Evening, 1 Hour After Drug Application	-2.45 Units on a scale Standard Error 0.252	-3.26 Units on a scale Standard Error 0.160	-2.33 Units on a scale Standard Error 0.160	-3.05 Units on a scale Standard Error 0.159

SECONDARY outcome

Timeframe: 0 to 72 hours after start of treatment

Population: Treated set (TS)

This is a key secondary endpoint. AUC for POMwp calculated from 0 to 72 h that is for first three treatment days using the trapezoidal rule divided by the observation time. The results presented here are adjusted mean and standard error for POMwp AUC (0-72 h) in centimeters (cm). The AUC represents POMwp as an average over the first 3 treatment days (Day 1 until Day 4 morning) - it is not meant here as a pharmacokinetics (PK) parameter (concentration over time).

Outcome measures

Outcome measures
Measure	Placebo Gel n=75 Participants Patients were topically applied matching Placebo 2 gram (g) gel, twice daily with 12 ± 4 hours (h) between applications.	Capsaicin (0.075%) Gel n=223 Participants Patients were topically applied Capsaicin 2 g gel (1.5 milligram (mg) Capsaicin), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) Gel n=223 Participants Patients were topically applied Diclofenac 2 g gel (40 milligram (mg) Diclofenac), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) +Capsaicin (0.075%) Gel n=225 Participants Patients were topically applied Diclofenac + Capsaicin 2 g gel (40 mg diclofenac, 1.5 mg capsaicin), twice daily with 12 ± 4 hours (h) between applications.
POMwp Area Under the Curve (AUC) Calculated From 0 to 72 Hours (h) (POMwp AUC(0-72 h))	4.62 cm Standard Error 0.213	3.95 cm Standard Error 0.145	4.81 cm Standard Error 0.145	4.25 cm Standard Error 0.143

SECONDARY outcome

Timeframe: 0 to 120 hours after start of treatment

Population: TS

This is a key secondary endpoint. AUC for POMwp calculated from 0 to 120 h that is for first five treatment days using the trapezoidal rule divided by the observation time. The results presented here are adjusted mean and standard error for POMwp AUC (0-120 h) in centimeters (cm). The AUC represents POMwp as an average over the first 5 treatment days (Day 1 until Day 6 morning) - it is not meant here as a PK parameter (concentration over time).

Outcome measures

Outcome measures
Measure	Placebo Gel n=75 Participants Patients were topically applied matching Placebo 2 gram (g) gel, twice daily with 12 ± 4 hours (h) between applications.	Capsaicin (0.075%) Gel n=223 Participants Patients were topically applied Capsaicin 2 g gel (1.5 milligram (mg) Capsaicin), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) Gel n=223 Participants Patients were topically applied Diclofenac 2 g gel (40 milligram (mg) Diclofenac), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) +Capsaicin (0.075%) Gel n=225 Participants Patients were topically applied Diclofenac + Capsaicin 2 g gel (40 mg diclofenac, 1.5 mg capsaicin), twice daily with 12 ± 4 hours (h) between applications.
POMwp Area Under the Curve (AUC) Calculated From 0 to 120 Hours (h) (POMwp AUC(0-120 h))	3.92 cm Standard Error 0.230	3.10 cm Standard Error 0.156	4.10 cm Standard Error 0.156	3.41 cm Standard Error 0.154

SECONDARY outcome

Timeframe: Baseline and day 2

Population: TS

This outcome measures the pattern of number of patients with a decrease in POMwp of at least 30% from baseline at 1 hour after dosing on Day 2 evening.

Outcome measures

Outcome measures
Measure	Placebo Gel n=75 Participants Patients were topically applied matching Placebo 2 gram (g) gel, twice daily with 12 ± 4 hours (h) between applications.	Capsaicin (0.075%) Gel n=223 Participants Patients were topically applied Capsaicin 2 g gel (1.5 milligram (mg) Capsaicin), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) Gel n=223 Participants Patients were topically applied Diclofenac 2 g gel (40 milligram (mg) Diclofenac), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) +Capsaicin (0.075%) Gel n=225 Participants Patients were topically applied Diclofenac + Capsaicin 2 g gel (40 mg diclofenac, 1.5 mg capsaicin), twice daily with 12 ± 4 hours (h) between applications.
Number of Patients With Decrease in POMwp of at Least 30% From Baseline	34 Participants	150 Participants	107 Participants	134 Participants

SECONDARY outcome

Timeframe: Baseline and day 2

Population: TS

This outcome measures the pattern of number of patients with a decrease in POMwp of at least 50% from baseline at 1 hour after dosing on Day 2 evening.

Outcome measures

Outcome measures
Measure	Placebo Gel n=75 Participants Patients were topically applied matching Placebo 2 gram (g) gel, twice daily with 12 ± 4 hours (h) between applications.	Capsaicin (0.075%) Gel n=223 Participants Patients were topically applied Capsaicin 2 g gel (1.5 milligram (mg) Capsaicin), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) Gel n=223 Participants Patients were topically applied Diclofenac 2 g gel (40 milligram (mg) Diclofenac), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) +Capsaicin (0.075%) Gel n=225 Participants Patients were topically applied Diclofenac + Capsaicin 2 g gel (40 mg diclofenac, 1.5 mg capsaicin), twice daily with 12 ± 4 hours (h) between applications.
Number of Patients With Decrease in POMwp of at Least 50% From Baseline	20 Participants	95 Participants	50 Participants	85 Participants

SECONDARY outcome

Timeframe: Baseline and Day 6

Population: TS

Pain on movement (POM) was used to assess pain measurement for back and neck pain. The standardized movements have been established for which the measurement was taken. POMwp was the POM measure that gave the highest score at baseline; i.e. POM of worst procedure. Pain intensity was assessed at rest after standing in an upright position relatively motionless for 1 minute. The pain was evaluated by asking patient 'How would you rate your pain right now?' and by using a visual analogue scale (VAS) ranging from 0-10 cm wherein 0 cm = no pain to 10 cm = worst pain possible. The results presented here are adjusted mean change from baseline and standard error for POMwp in centimeters (cm).

Outcome measures

Outcome measures
Measure	Placebo Gel n=75 Participants Patients were topically applied matching Placebo 2 gram (g) gel, twice daily with 12 ± 4 hours (h) between applications.	Capsaicin (0.075%) Gel n=223 Participants Patients were topically applied Capsaicin 2 g gel (1.5 milligram (mg) Capsaicin), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) Gel n=223 Participants Patients were topically applied Diclofenac 2 g gel (40 milligram (mg) Diclofenac), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) +Capsaicin (0.075%) Gel n=225 Participants Patients were topically applied Diclofenac + Capsaicin 2 g gel (40 mg diclofenac, 1.5 mg capsaicin), twice daily with 12 ± 4 hours (h) between applications.
Change From Baseline in POMwp (cm) at Day 6 Morning	-3.83 Units on a scale Standard Error 0.282	-5.08 Units on a scale Standard Error 0.175	-3.77 Units on a scale Standard Error 0.175	-4.88 Units on a scale Standard Error 0.174

SECONDARY outcome

Timeframe: Baseline and Day 2

Population: TS

PA is a method described to determine pressure pain threshold (PPT) by applying controlled pressure to a given body point. The results presented here are adjusted mean change from baseline and standard error for PA.

Outcome measures

Outcome measures
Measure	Placebo Gel n=75 Participants Patients were topically applied matching Placebo 2 gram (g) gel, twice daily with 12 ± 4 hours (h) between applications.	Capsaicin (0.075%) Gel n=223 Participants Patients were topically applied Capsaicin 2 g gel (1.5 milligram (mg) Capsaicin), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) Gel n=223 Participants Patients were topically applied Diclofenac 2 g gel (40 milligram (mg) Diclofenac), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) +Capsaicin (0.075%) Gel n=225 Participants Patients were topically applied Diclofenac + Capsaicin 2 g gel (40 mg diclofenac, 1.5 mg capsaicin), twice daily with 12 ± 4 hours (h) between applications.
Change From Baseline in Pressure Algometry (PA) at Day 2 Evening, Before Drug Application	3.89 Newton/centimeter square (N/cm^2) Standard Error 0.795	3.46 Newton/centimeter square (N/cm^2) Standard Error 0.526	3.00 Newton/centimeter square (N/cm^2) Standard Error 0.530	3.77 Newton/centimeter square (N/cm^2) Standard Error 0.526

SECONDARY outcome

Timeframe: Baseline and Day 6

Population: TS

Outcome measures

Outcome measures
Measure	Placebo Gel n=75 Participants Patients were topically applied matching Placebo 2 gram (g) gel, twice daily with 12 ± 4 hours (h) between applications.	Capsaicin (0.075%) Gel n=223 Participants Patients were topically applied Capsaicin 2 g gel (1.5 milligram (mg) Capsaicin), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) Gel n=223 Participants Patients were topically applied Diclofenac 2 g gel (40 milligram (mg) Diclofenac), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) +Capsaicin (0.075%) Gel n=225 Participants Patients were topically applied Diclofenac + Capsaicin 2 g gel (40 mg diclofenac, 1.5 mg capsaicin), twice daily with 12 ± 4 hours (h) between applications.
Change From Baseline in Pressure Algometry (PA) at Day 6 Morning	8.01 Newton/centimeter square (N/cm^2) Standard Error 1.199	9.38 Newton/centimeter square (N/cm^2) Standard Error 0.737	7.64 Newton/centimeter square (N/cm^2) Standard Error 0.740	9.66 Newton/centimeter square (N/cm^2) Standard Error 0.737

Adverse Events

Placebo Gel

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Capsaicin (0.075%) Gel

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Diclofenac (2%) Gel

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Diclofenac (2%) +Capsaicin (0.075%) Gel

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo Gel n=75 participants at risk Patients were topically applied matching Placebo 2 gram (g) gel, twice daily with 12 ± 4 hours (h) between applications.	Capsaicin (0.075%) Gel n=223 participants at risk Patients were topically applied Capsaicin 2 g gel (1.5 milligram (mg) Capsaicin), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) Gel n=223 participants at risk Patients were topically applied Diclofenac 2 g gel (40 milligram (mg) Diclofenac), twice daily with 12 ± 4 hours (h) between applications.	Diclofenac (2%) +Capsaicin (0.075%) Gel n=225 participants at risk Patients were topically applied Diclofenac + Capsaicin 2 g gel (40 mg diclofenac, 1.5 mg capsaicin), twice daily with 12 ± 4 hours (h) between applications.
General disorders Burning sensation	0.00% 0/75 • From first drug administration until 2 days after the last drug administration, i.e. up to 8 days. An adverse event (AE) was defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event did not necessarily have to have a causal relationship with this treatment. TS (as treated) has been used for assessment of AEs.	7.2% 16/223 • From first drug administration until 2 days after the last drug administration, i.e. up to 8 days. An adverse event (AE) was defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event did not necessarily have to have a causal relationship with this treatment. TS (as treated) has been used for assessment of AEs.	0.45% 1/223 • From first drug administration until 2 days after the last drug administration, i.e. up to 8 days. An adverse event (AE) was defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event did not necessarily have to have a causal relationship with this treatment. TS (as treated) has been used for assessment of AEs.	5.3% 12/225 • From first drug administration until 2 days after the last drug administration, i.e. up to 8 days. An adverse event (AE) was defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event did not necessarily have to have a causal relationship with this treatment. TS (as treated) has been used for assessment of AEs.
Infections and infestations Nasopharyngitis	5.3% 4/75 • From first drug administration until 2 days after the last drug administration, i.e. up to 8 days. An adverse event (AE) was defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event did not necessarily have to have a causal relationship with this treatment. TS (as treated) has been used for assessment of AEs.	4.0% 9/223 • From first drug administration until 2 days after the last drug administration, i.e. up to 8 days. An adverse event (AE) was defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event did not necessarily have to have a causal relationship with this treatment. TS (as treated) has been used for assessment of AEs.	1.8% 4/223 • From first drug administration until 2 days after the last drug administration, i.e. up to 8 days. An adverse event (AE) was defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event did not necessarily have to have a causal relationship with this treatment. TS (as treated) has been used for assessment of AEs.	1.3% 3/225 • From first drug administration until 2 days after the last drug administration, i.e. up to 8 days. An adverse event (AE) was defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event did not necessarily have to have a causal relationship with this treatment. TS (as treated) has been used for assessment of AEs.
Skin and subcutaneous tissue disorders Skin burning sensation	0.00% 0/75 • From first drug administration until 2 days after the last drug administration, i.e. up to 8 days. An adverse event (AE) was defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event did not necessarily have to have a causal relationship with this treatment. TS (as treated) has been used for assessment of AEs.	3.1% 7/223 • From first drug administration until 2 days after the last drug administration, i.e. up to 8 days. An adverse event (AE) was defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event did not necessarily have to have a causal relationship with this treatment. TS (as treated) has been used for assessment of AEs.	0.90% 2/223 • From first drug administration until 2 days after the last drug administration, i.e. up to 8 days. An adverse event (AE) was defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event did not necessarily have to have a causal relationship with this treatment. TS (as treated) has been used for assessment of AEs.	5.3% 12/225 • From first drug administration until 2 days after the last drug administration, i.e. up to 8 days. An adverse event (AE) was defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event did not necessarily have to have a causal relationship with this treatment. TS (as treated) has been used for assessment of AEs.

Additional Information

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