Table 3.

Examples of Medical Dictionary for Regulatory Activities (MedDRA) coding from the analysis.

#	Patient submission	PLMa action	PLM MedDRA coding		FDAb reviewer assessment		Outcome
			LLTc	PTd
1	Pruritis	Merged into PLM symptom “Itching”	Itching	Pruritus		Coding appropriate		N/Ae
2	Rash on chest & neck	Merged into PLM symptoms “Rash on chest” and “Rash on neck”	Skin rash; neck rash	Rash		Coding appropriate		N/A
3	Drop foot from surgery	Merged into PLM symptom “Foot drop”	Foot drop	Peroneal nerve palsy		Coding appropriate; however, more specific term is available. Recommend: LLT Peroneal nerve palsy postoperative; PT Peroneal nerve palsy postoperative		Coding was not changed because of the PLM conceptual approach to coding to more general term
4	Sexual dysfunction/no libido	Merged into PLM symptom “Sexual dysfunction”	Sexual dysfunction	Sexual dysfunction		Coding appropriate		N/A
5	Irrational emotions	Merged into PLM symptom “Irrational emotions”	Mixed disturbance of conduct and emotions	Antisocial behavior		Incorrect coding; recommend coding to: LLT Emotional disorder; PT Emotional disorder		Coding updated
6	Cardiac arrhythmia	Merged into PLM symptom “Irregular heartbeat (cardiac arrhythmia)”	Heartbeats irregular	Heart rate irregular		Incorrect coding; recommend coding to: LLT Cardiac Arrhythmia; PT Arrhythmia		Coding updated
7	Increased INRf	Merged into PLM symptom “High INR”	INR abnormal	INR abnormal		Incorrect coding; recommend coding to: LLT INR increased; PT INR increased		Coding updated
8	I was stumbling, falling and tripping, my thinking process was very slow and my memory was failing too	Merged into PLM symptoms “Memory problems,” “Slowed thinking,” and “Tripping and stumbling”	Memory disturbance; slowed thinking; muscular incoordination	Memory impairment; Bradyphrenia; coordination abnormal		Missed concept. Report of “falling” is missing; falls are an important patient safety issue which should be captured. For stumbling and tripping, there is LLT Stumbling and LLT Gait tripping, both under PT Gait disturbance		Coding updated to include additional information
9	Back pain and nausea and vomiting	Merged into PLM symptoms “Nausea and vomiting” and “Back pain”	Vomiting; back pain	Vomiting; back pain		Missed concept (nausea)		PLM symptom “Nausea and vomiting” retired. The separate symptoms “Nausea” and “Vomiting” remain available
10	Gluten sensitivity	Merged into PLM symptom “Gluten intolerance”	Gluten intolerance	Celiac disease		Outdated MedDRA version; coding appropriate for this version of MedDRA, but more appropriate terms available in newer versions. Recommend coding to: LLT Gluten sensitivity; PT Gluten sensitivity		Coding updated after upgrade to more recent MedDRA version
11	Shocked by electricity house	Merged into PLM symptom “Seizures (grand mal or tonic–clonic)”	Tonic-clonic seizures	Grand mal convulsion		Unable to assess. Not clear from information how this could be determined		Communications with patient indicated this was reference to seizures

^aPLM: PatientsLikeMe.

^bFDA: Food and Drug Administration.

^cLLT: lowest-level term.

^dPT: preferred term.

^eN/A: not applicable.

^fINR: international normalized ratio